NCT00064077 · STUDY IN CONTEXT

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

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

Evaluable (treatment)

→

secondary · POSTED

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.

Evaluable (treatment)

→

secondary · POSTED

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Evaluable (treatment)

→

secondary · POSTED

The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx 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. 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 subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.

Patients who provided baseline and ≥ one follow-up assessments

→

secondary · POSTED

Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.

Patients who provided baseline and ≥ one follow-up assessments

→

secondary · POSTED

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 baseline and ≥ one follow-up assessments

→

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 as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id: NCT00064077
qol key: qol-0003
source section id: NCT00064077-om-0003
source outcome index: 3
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
measure definition: The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx 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. 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 subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
time frame: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients who provided baseline and ≥ one follow-up assessments
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Brief Pain Inventory · Pain, Assessed by Brief Pain Inventory

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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id: NCT00064077
qol key: qol-0004
source section id: NCT00064077-om-0004
source outcome index: 4
instrument: Brief Pain Inventory
instrument basis: matched 'brief pain inventory' in the study's own wording
scale title: Pain, Assessed by Brief Pain Inventory
measure definition: Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
time frame: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients who provided baseline and ≥ one follow-up assessments
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 Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id: NCT00064077
qol key: qol-0005
source section id: NCT00064077-om-0005
source outcome index: 5
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
measure definition: 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-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id: NCT00064077
trial label: Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 4
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0000
source section id
NCT00064077-om-0000
source outcome index
0
endpoint
Duration of Overall Survival (OS)
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
Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable (treatment)
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0001
source section id
NCT00064077-om-0001
source outcome index
1
endpoint
Frequency of Response Using RECIST Version 1.0
endpoint definition
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
time origin
Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable (treatment)
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0002
source section id
NCT00064077-om-0002
source outcome index
2
endpoint
Duration of Progression-free Survival (PFS)
endpoint definition
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
time origin
Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable (treatment)
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0003
source section id
NCT00064077-om-0003
source outcome index
3
endpoint
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
endpoint definition
The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx 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. 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 subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
time origin
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0004
source section id
NCT00064077-om-0004
source outcome index
4
endpoint
Pain, Assessed by Brief Pain Inventory
endpoint definition
Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
time origin
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0005
source section id
NCT00064077-om-0005
source outcome index
5
endpoint
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
endpoint definition
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-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0000
arm key
OG000
arm label
Arm I (Paclitaxel, Cisplatin)
regimen
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0000
arm key
OG001
arm label
Arm II (Vinorelbine, Cisplatin)
regimen
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0000
arm key
OG002
arm label
Arm III (Gemcitabine, Cisplatin)
regimen
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0000
arm key
OG003
arm label
Arm IV (Topotecan, Cisplatin)
regimen
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0001
arm key
OG000
arm label
Arm I (Paclitaxel, Cisplatin)
regimen
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0001
arm key
OG001
arm label
Arm II (Vinorelbine, Cisplatin)
regimen
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0001
arm key
OG002
arm label
Arm III (Gemcitabine, Cisplatin)
regimen
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0001
arm key
OG003
arm label
Arm IV (Topotecan, Cisplatin)
regimen
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0002
arm key
OG000
arm label
Arm I (Paclitaxel, Cisplatin)
regimen
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0002
arm key
OG001
arm label
Arm II (Vinorelbine, Cisplatin)
regimen
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0002
arm key
OG002
arm label
Arm III (Gemcitabine, Cisplatin)
regimen
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
analyzed count
112
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
outcome key
om-0002
arm key
OG003
arm label
Arm IV (Topotecan, Cisplatin)
regimen
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00064077-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
harm key
EG000
source section id
NCT00064077-ae
event group key
EG000
event group label
Arm I (Paclitaxel, Cisplatin)
serious affected
42
serious at risk
103
other affected
101
other at risk
103
frequency threshold
0
collection period
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
harm key
EG001
source section id
NCT00064077-ae
event group key
EG001
event group label
Arm II (Vinorelbine, Cisplatin)
serious affected
39
serious at risk
108
other affected
105
other at risk
108
frequency threshold
0
collection period
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
harm key
EG002
source section id
NCT00064077-ae
event group key
EG002
event group label
Arm III (Gemcitabine, Cisplatin)
serious affected
38
serious at risk
112
other affected
109
other at risk
112
frequency threshold
0
collection period
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
harm key
EG003
source section id
NCT00064077-ae
event group key
EG003
event group label
Arm IV (Topotecan, Cisplatin)
serious affected
38
serious at risk
111
other affected
108
other at risk
111
frequency threshold
0
collection period
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
qol key
qol-0003
source section id
NCT00064077-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
measure definition
The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx 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. 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 subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
time frame
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
qol key
qol-0004
source section id
NCT00064077-om-0004
source outcome index
4
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Pain, Assessed by Brief Pain Inventory
measure definition
Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
time frame
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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-cervical-cancer-stage-ivb-recurrent-cf378e66
nct id
NCT00064077
qol key
qol-0005
source section id
NCT00064077-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
measure definition
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-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patients who provided baseline and ≥ one follow-up assessments
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