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← Cervical Cancer

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: 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

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
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
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
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
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
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
4
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    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