|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Condition: |
Cancer of Cervix |
| Interventions: |
Drug: Gemcitabine Drug: Cisplatin Radiation: Brachytherapy Radiation: Pelvic radiation |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Gemcitabine/Cisplatin/Radiation |
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week Two week rest period with no chemotherapy or radiation Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles |
| Cisplatin/Radiation |
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week |
| Gemcitabine/Cisplatin/Radiation | Cisplatin/Radiation | |
|---|---|---|
| STARTED | 259 | 256 |
| COMPLETED | 217 | 244 |
| NOT COMPLETED | 42 | 12 |
| Adverse Event | 18 | 1 |
| Lost to Follow-up | 2 | 0 |
| Patient Moved | 0 | 1 |
| Withdrawal by Subject | 9 | 3 |
| Protocol Entry Criteria Not Met | 2 | 1 |
| Clinical Relapse | 2 | 1 |
| Lack of Efficacy, Progressive Disease | 1 | 2 |
| Lack of Efficacy, Stable Disease | 1 | 0 |
| Physician Decision | 3 | 1 |
| Death from Study Drug Toxicity | 2 | 0 |
| Protocol Violation | 1 | 1 |
| Death from Other Cause | 1 | 0 |
| Reason Not Specified | 0 | 1 |
Outcome Measures
| 1. 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 ] |
| 2. 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 ] |
| 3. 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 ] |
| 4. 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 ] |
| 5. 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) ] |
| 6. 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 ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 4015, B9E-MC-JHQS |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 30, 2009 |
| Last Updated: | August 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00191100 History of Changes |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
