Trial · NCT00064077
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
NCT00064077, Phase 3, Completed, Gynecologic Oncology Group; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix. Trials, record NCT00064077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064077
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
- NCT number
- NCT00064077
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 513 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVB Cervical Cancer
- Interventions
- Cisplatin, Gemcitabine Hydrochloride, Paclitaxel, Quality-of-Life Assessment, Topotecan Hydrochloride, Vinorelbine Tartrate
- First posted
- 2003-07-09
- Last updated
- 2018-10-17
- Results first posted
- 2018-08-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Overall Survival (OS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
| Secondary | Frequency of Response Using RECIST Version 1.0 | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | 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. |
| Secondary | Duration of Progression-free Survival (PFS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | 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. |
| Secondary | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
| Secondary | Pain, Assessed by Brief Pain Inventory | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
| Secondary | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Overall Survival (OS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Evaluable (treatment) | months | MEDIAN |
| SECONDARY | Frequency of Response Using RECIST Version 1.0 | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Evaluable (treatment) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Progression-free Survival (PFS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Evaluable (treatment) | months | MEDIAN |
| SECONDARY | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | Patients who provided baseline and ≥ one follow-up assessments | units on a scale | MEAN |
| SECONDARY | Pain, Assessed by Brief Pain Inventory | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | Patients who provided baseline and ≥ one follow-up assessments | units on a scale | MEAN |
| SECONDARY | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | Patients who provided baseline and ≥ one follow-up assessments | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Overall Survival (OS) | Arm I (Paclitaxel, Cisplatin) | 12.87 | 95% Confidence Interval 10.02 to 16.76 | months | |
| Duration of Overall Survival (OS) | Arm II (Vinorelbine, Cisplatin) | 9.99 | 95% Confidence Interval 8.25 to 12.25 | months | |
| Duration of Overall Survival (OS) | Arm III (Gemcitabine, Cisplatin) | 10.28 | 95% Confidence Interval 7.62 to 11.60 | months | |
| Duration of Overall Survival (OS) | Arm IV (Topotecan, Cisplatin) | 10.25 | 95% Confidence Interval 8.61 to 11.66 | months | |
| Frequency of Response Using RECIST Version 1.0 | Arm I (Paclitaxel, Cisplatin) | Complete Response | 3 | Participants | |
| Frequency of Response Using RECIST Version 1.0 | Arm II (Vinorelbine, Cisplatin) | Complete Response | 8 | Participants | |
| Frequency of Response Using RECIST Version 1.0 | Arm III (Gemcitabine, Cisplatin) | Complete Response | 1 | Participants | |
| Frequency of Response Using RECIST Version 1.0 | Arm IV (Topotecan, Cisplatin) | Complete Response | 2 | Participants | |
| Frequency of Response Using RECIST Version 1.0 | Arm I (Paclitaxel, Cisplatin) | Partial Response | 27 | Participants | |
| Frequency of Response Using RECIST Version 1.0 | Arm II (Vinorelbine, Cisplatin) | Partial Response | 20 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Paclitaxel, Cisplatin) | 118 | |
| Overall Study | STARTED | Arm II (Vinorelbine, Cisplatin) | 117 | |
| Overall Study | STARTED | Arm III (Gemcitabine, Cisplatin) | 119 | |
| Overall Study | STARTED | Arm IV (Topotecan, Cisplatin) | 118 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel, Cisplatin) | 103 | |
| Overall Study | COMPLETED | Arm II (Vinorelbine, Cisplatin) | 108 | |
| Overall Study | COMPLETED | Arm III (Gemcitabine, Cisplatin) | 112 | |
| Overall Study | COMPLETED | Arm IV (Topotecan, Cisplatin) | 111 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel, Cisplatin) | 15 | |
| Overall Study | NOT COMPLETED | Arm II (Vinorelbine, Cisplatin) | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events424
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Cisplatin) | 92 | 103 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm II (Vinorelbine, Cisplatin) | 98 | 108 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm III (Gemcitabine, Cisplatin) | 90 | 112 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm IV (Topotecan, Cisplatin) | 102 | 111 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Cisplatin) | 94 | 103 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Vinorelbine, Cisplatin) | 100 | 108 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Gemcitabine, Cisplatin) | 104 | 112 | |
| other | Anemia | Blood and lymphatic system disorders | Arm IV (Topotecan, Cisplatin) | 106 | 111 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Cisplatin) | 36 | 103 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm II (Vinorelbine, Cisplatin) | 32 | 108 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Paclitaxel, Cisplatin) | ||
| Total, all-cause mortality | Arm II (Vinorelbine, Cisplatin) | ||
| Total, all-cause mortality | Arm III (Gemcitabine, Cisplatin) | ||
| Total, all-cause mortality | Arm IV (Topotecan, Cisplatin) | ||
| Total, other adverse events | Arm I (Paclitaxel, Cisplatin) | 101 | 103 |
| Total, other adverse events | Arm II (Vinorelbine, Cisplatin) | 105 | 108 |
| Total, other adverse events | Arm III (Gemcitabine, Cisplatin) | 109 | 112 |
| Total, other adverse events | Arm IV (Topotecan, Cisplatin) | 108 | 111 |
| Total, serious adverse events | Arm I (Paclitaxel, Cisplatin) | 42 | 103 |
| Total, serious adverse events | Arm II (Vinorelbine, Cisplatin) | 39 | 108 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00064077
GET https://conductscience.org/api/trials/v1/NCT00064077/results?page=2