NCT01081262 · STUDY IN CONTEXT

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stag

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.

All randomized patients

→

secondary · POSTED

Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.

Eligible and treated patients

→

secondary · POSTED

Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

All Randomized Patients

→

secondary · POSTED

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR

All randomized patients with measurable disease

→

secondary · POSTED

Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.

Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.

→

secondary · POSTED

Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial 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). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL

All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.

→

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 Neurotoxicity

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-malignant-fallopian-tube-neoplasm
nct id: NCT01081262
qol key: qol-0004
source section id: NCT01081262-om-0004
source outcome index: 4
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Patient Reported Neurotoxicity
measure definition: Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
time frame: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.
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

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-malignant-fallopian-tube-neoplasm
nct id: NCT01081262
qol key: qol-0005
source section id: NCT01081262-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
measure definition: Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial 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). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
time frame: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.
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-malignant-fallopian-tube-neoplasm
nct id: NCT01081262
trial label: Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stag
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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 4
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0000
source section id
NCT01081262-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
time origin
Up to five years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0001
source section id
NCT01081262-om-0001
source outcome index
1
endpoint
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
endpoint definition
Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.
time origin
Every cycle while on treatment, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0002
source section id
NCT01081262-om-0002
source outcome index
2
endpoint
Progression-free Survival
endpoint definition
Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Patients
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0003
source section id
NCT01081262-om-0003
source outcome index
3
endpoint
Objective Tumor Response
endpoint definition
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR
time origin
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients with measurable disease
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0004
source section id
NCT01081262-om-0004
source outcome index
4
endpoint
Patient Reported Neurotoxicity
endpoint definition
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
time origin
baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0005
source section id
NCT01081262-om-0005
source outcome index
5
endpoint
Patient Reported Quality of Life
endpoint definition
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial 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). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
time origin
baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0000
arm key
OG000
arm label
Arm I (Carboplatin and Paclitaxel)
regimen
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0000
arm key
OG001
arm label
Arm II (Oxaliplatin and Capecitabine)
regimen
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0000
arm key
OG002
arm label
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
regimen
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0000
arm key
OG003
arm label
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
regimen
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0001
arm key
OG000
arm label
Arm I (Carboplatin and Paclitaxel)
regimen
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0001
arm key
OG001
arm label
Arm II (Oxaliplatin and Capecitabine)
regimen
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0001
arm key
OG002
arm label
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
regimen
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0001
arm key
OG003
arm label
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
regimen
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0002
arm key
OG000
arm label
Arm I (Carboplatin and Paclitaxel)
regimen
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0002
arm key
OG001
arm label
Arm II (Oxaliplatin and Capecitabine)
regimen
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0002
arm key
OG002
arm label
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
regimen
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
outcome key
om-0002
arm key
OG003
arm label
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
regimen
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01081262-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
harm key
EG000
source section id
NCT01081262-ae
event group key
EG000
event group label
Arm I (Carboplatin and Paclitaxel)
serious affected
3
serious at risk
13
other affected
13
other at risk
13
frequency threshold
0
collection period
Study treatment and up to 5 years after treatment discontinuation
event definition
Source null
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
harm key
EG001
source section id
NCT01081262-ae
event group key
EG001
event group label
Arm II (Oxaliplatin and Capecitabine)
serious affected
4
serious at risk
13
other affected
13
other at risk
13
frequency threshold
0
collection period
Study treatment and up to 5 years after treatment discontinuation
event definition
Source null
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
harm key
EG002
source section id
NCT01081262-ae
event group key
EG002
event group label
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
serious affected
2
serious at risk
13
other affected
13
other at risk
13
frequency threshold
0
collection period
Study treatment and up to 5 years after treatment discontinuation
event definition
Source null
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
harm key
EG003
source section id
NCT01081262-ae
event group key
EG003
event group label
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
serious affected
3
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
Study treatment and up to 5 years after treatment discontinuation
event definition
Source null
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
qol key
qol-0004
source section id
NCT01081262-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient Reported Neurotoxicity
measure definition
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
time frame
baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.
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-malignant-fallopian-tube-neoplasm
nct id
NCT01081262
qol key
qol-0005
source section id
NCT01081262-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
measure definition
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial 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). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
time frame
baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.
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