Trials / Completed
CompletedNCT00191100
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 515 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine | |
| DRUG | Cisplatin | |
| RADIATION | Brachytherapy | Brachytherapy, 30-35 Gy over 1 week |
| RADIATION | Pelvic radiation | Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2005-09-19
- Last updated
- 2009-08-11
- Results posted
- 2009-05-25
Locations
7 sites across 7 countries: Argentina, Bosnia and Herzegovina, India, Mexico, Pakistan, Peru, Thailand
Source: ClinicalTrials.gov record NCT00191100. Inclusion in this directory is not an endorsement.