NCT00565851 · STUDY IN CONTEXT

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fall

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.

All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)

→

primary · POSTED

The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.

All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).

→

secondary · POSTED

Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.

All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).

→

secondary · POSTED

Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.

All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).

→

secondary · POSTED

Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))

Eligible and treated participants

→

secondary · POSTED

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.

Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Patient Reported Quality of Life (Chemotherapy Analysis)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-transitional-cell-carcinoma
nct id: NCT00565851
qol key: qol-0005
source section id: NCT00565851-om-0005
source outcome index: 5
instrument: FACT
instrument basis: matched 'fact-o' in the study's own wording
scale title: Patient Reported Quality of Life (Chemotherapy Analysis)
measure definition: Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
time frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

SF-36 / SF-12 · Patient Reported Physical Function (Chemotherapy Analysis)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-transitional-cell-carcinoma
nct id: NCT00565851
qol key: qol-0006
source section id: NCT00565851-om-0006
source outcome index: 6
instrument: SF-36 / SF-12
instrument basis: matched 'sf-36' in the study's own wording
scale title: Patient Reported Physical Function (Chemotherapy Analysis)
measure definition: Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
time frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Patient Reported Quality of Life (Surgery Analysis)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-transitional-cell-carcinoma
nct id: NCT00565851
qol key: qol-0007
source section id: NCT00565851-om-0007
source outcome index: 7
instrument: FACT
instrument basis: matched 'fact-o' in the study's own wording
scale title: Patient Reported Quality of Life (Surgery Analysis)
measure definition: Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
time frame: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

SF-36 / SF-12 · Patient Reported Physical Functioning (Surgery Analysis)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-transitional-cell-carcinoma
nct id: NCT00565851
qol key: qol-0008
source section id: NCT00565851-om-0008
source outcome index: 8
instrument: SF-36 / SF-12
instrument basis: matched 'sf-36' in the study's own wording
scale title: Patient Reported Physical Functioning (Surgery Analysis)
measure definition: Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
time frame: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-transitional-cell-carcinoma
nct id: NCT00565851
trial label: Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fall
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 8
qol Count: 4

outcomes

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0000
source section id
NCT00565851-om-0000
source outcome index
0
endpoint
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
endpoint definition
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
time origin
The time frame is 82.5 months (median duration of follow-up)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0001
source section id
NCT00565851-om-0001
source outcome index
1
endpoint
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
endpoint definition
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
time origin
The time frame is 82.5 months (median duration of follow-up).
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0002
source section id
NCT00565851-om-0002
source outcome index
2
endpoint
Progression-free Survival (Chemotherapy Analysis)
endpoint definition
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
time origin
Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0003
source section id
NCT00565851-om-0003
source outcome index
3
endpoint
Progression Free Survival (Surgery Analysis)
endpoint definition
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
time origin
Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0004
source section id
NCT00565851-om-0004
source outcome index
4
endpoint
Summary of Adverse Events (CTCAE Version 4.0)
endpoint definition
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
time origin
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0005
source section id
NCT00565851-om-0005
source outcome index
5
endpoint
Patient Reported Quality of Life (Chemotherapy Analysis)
endpoint definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
time origin
1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0000
arm key
OG000
arm label
No Cytoreductive Surgery
regimen
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
analyzed count
245
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0000
arm key
OG001
arm label
Cytoreductive Surgery
regimen
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
analyzed count
240
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0001
arm key
OG000
arm label
Paclitaxel and Carboplatin Chemotherapy
regimen
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
analyzed count
337
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0001
arm key
OG001
arm label
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
regimen
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
analyzed count
337
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0002
arm key
OG000
arm label
Paclitaxel and Carboplatin Chemotherapy
regimen
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
analyzed count
337
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0002
arm key
OG001
arm label
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
regimen
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
analyzed count
337
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0003
arm key
OG000
arm label
No Cytoreductive Surgery
regimen
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
analyzed count
245
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0003
arm key
OG001
arm label
Cytoreductive Surgery
regimen
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
analyzed count
240
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0004
arm key
OG000
arm label
Arm I (no Surgery; Carboplatin and Paclitaxel)
regimen
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
316
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0004
arm key
OG001
arm label
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
regimen
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
456
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0004
arm key
OG002
arm label
Arm III (Surgery; Carboplatin and Paclitaxel)
regimen
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0004#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
outcome key
om-0004
arm key
OG003
arm label
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
regimen
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
165
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00565851-om-0004#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG000
source section id
NCT00565851-ae
event group key
EG000
event group label
Arm I (no Surgery; Carboplatin and Paclitaxel)
serious affected
37
serious at risk
316
other affected
304
other at risk
316
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG001
source section id
NCT00565851-ae
event group key
EG001
event group label
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
serious affected
104
serious at risk
456
other affected
376
other at risk
456
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG002
source section id
NCT00565851-ae
event group key
EG002
event group label
Arm III (Surgery; Carboplatin and Paclitaxel)
serious affected
1
serious at risk
33
other affected
29
other at risk
33
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG003
source section id
NCT00565851-ae
event group key
EG003
event group label
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
serious affected
24
serious at risk
165
other affected
77
other at risk
165
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG004
source section id
NCT00565851-ae
event group key
EG004
event group label
Arm V (no Surgery; Carboplatin and Gemcitabine)
serious affected
0
serious at risk
6
other affected
3
other at risk
6
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG005
source section id
NCT00565851-ae
event group key
EG005
event group label
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
serious affected
1
serious at risk
34
other affected
9
other at risk
34
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG006
source section id
NCT00565851-ae
event group key
EG006
event group label
Arm VII (Surgery; Carboplatin and Gemcitabine)
serious affected
2
serious at risk
5
other affected
3
other at risk
5
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
harm key
EG007
source section id
NCT00565851-ae
event group key
EG007
event group label
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
serious affected
2
serious at risk
37
other affected
9
other at risk
37
frequency threshold
0
collection period
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
event definition
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
qol key
qol-0005
source section id
NCT00565851-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-o' in the study's own wording
scale title
Patient Reported Quality of Life (Chemotherapy Analysis)
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
time frame
1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
qol key
qol-0006
source section id
NCT00565851-om-0006
source outcome index
6
instrument
SF-36 / SF-12
instrument basis
matched 'sf-36' in the study's own wording
scale title
Patient Reported Physical Function (Chemotherapy Analysis)
measure definition
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
time frame
1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
qol key
qol-0007
source section id
NCT00565851-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'fact-o' in the study's own wording
scale title
Patient Reported Quality of Life (Surgery Analysis)
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
time frame
1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT00565851
qol key
qol-0008
source section id
NCT00565851-om-0008
source outcome index
8
instrument
SF-36 / SF-12
instrument basis
matched 'sf-36' in the study's own wording
scale title
Patient Reported Physical Functioning (Surgery Analysis)
measure definition
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
time frame
1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice