Trial · NCT00191100
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
NCT00191100, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix. Trials, record NCT00191100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191100
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
- NCT number
- NCT00191100
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 515 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Cancer of Cervix
- Interventions
- Gemcitabine, Cisplatin, Brachytherapy, Pelvic radiation
- First posted
- 2005-09-19
- Last updated
- 2009-08-11
- Results first posted
- 2009-05-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented. |
| Secondary | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented. |
| Secondary | Local Failure Rate | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b). |
| Secondary | Tumor Response | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response. |
| Secondary | Number of Participants Who Died From Any Cause at Various Time Points | baseline to date of death from any cause (includes 60 month follow-up period) | Original outcome was Overall Survival, which was defined as time from baseline to death from any cause. |
| Secondary | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause. |
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 | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned. | participants | NUMBER |
| SECONDARY | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | participants | NUMBER |
| SECONDARY | Local Failure Rate | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received. | proportion of participants with PD | NUMBER |
| SECONDARY | Tumor Response | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned. | participants | NUMBER |
| SECONDARY | Number of Participants Who Died From Any Cause at Various Time Points | baseline to date of death from any cause (includes 60 month follow-up period) | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | participants | NUMBER |
| SECONDARY | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Gemcitabine/Cisplatin/Radiation | 3 Years: Number of Patients with Event | 55 | participants | |
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Cisplatin/Radiation | 3 Years: Number of Patients with Event | 83 | participants | |
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Gemcitabine/Cisplatin/Radiation | 3 Years: Number of Patients at Risk | 149 | participants | |
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Cisplatin/Radiation | 3 Years: Number of Patients at Risk | 141 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Gemcitabine/Cisplatin/Radiation | 3 Months: Number of Patients with Event | 5 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Cisplatin/Radiation | 3 Months: Number of Patients with Event | 8 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Gemcitabine/Cisplatin/Radiation | 3 Months: Number of Patients at Risk | 221 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Cisplatin/Radiation | 3 Months: Number of Patients at Risk | 238 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Gemcitabine/Cisplatin/Radiation | 6 Months: Number of Patients with Event | 10 | participants | |
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Cisplatin/Radiation | 6 Months: Number of Patients with Event | 25 | participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine/Cisplatin/Radiation | 259 | |
| Overall Study | STARTED | Cisplatin/Radiation | 256 | |
| Overall Study | COMPLETED | Gemcitabine/Cisplatin/Radiation | 217 | |
| Overall Study | COMPLETED | Cisplatin/Radiation | 244 | |
| Overall Study | NOT COMPLETED | Gemcitabine/Cisplatin/Radiation | 42 | |
| Overall Study | NOT COMPLETED | Cisplatin/Radiation | 12 |
Source ClinicalTrials.gov
Adverse events174
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 | Anaemia | Blood and lymphatic system disorders | Gemcitabine/Cisplatin/Radiation | 175 | 260 | 233 |
| other | Anaemia | Blood and lymphatic system disorders | Cisplatin/Radiation | 115 | 255 | 130 |
| other | Leukopenia | Blood and lymphatic system disorders | Gemcitabine/Cisplatin/Radiation | 145 | 260 | 271 |
| other | Leukopenia | Blood and lymphatic system disorders | Cisplatin/Radiation | 114 | 255 | 124 |
| other | Lymphopenia | Blood and lymphatic system disorders | Gemcitabine/Cisplatin/Radiation | 31 | 260 | 41 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cisplatin/Radiation | 31 | 255 | 32 |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine/Cisplatin/Radiation | 193 | 260 | 378 |
| other | Neutropenia | Blood and lymphatic system disorders | Cisplatin/Radiation | 74 | 255 | 78 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine/Cisplatin/Radiation | 66 | 260 | 79 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cisplatin/Radiation | 30 | 255 | 30 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine/Cisplatin/Radiation | ||
| Total, all-cause mortality | Cisplatin/Radiation | ||
| Total, other adverse events | Gemcitabine/Cisplatin/Radiation | 259 | |
| Total, other adverse events | Cisplatin/Radiation | 251 | |
| Total, serious adverse events | Gemcitabine/Cisplatin/Radiation | 44 | |
| Total, serious adverse events | Cisplatin/Radiation | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21444871 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT00191100
GET https://conductscience.org/api/trials/v1/NCT00191100/results?page=2