Phase 3
N=515
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
Cancer of Cervix
Bottom Line
View on ClinicalTrials.gov: NCT00191100 ↗Enrolled (actual)
515
Serious AEs
—
Results posted
May 2009
Primary outcome: Primary: Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years — 55; 83; 149; 141 participants — p=0.029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gemcitabine (Drug); Cisplatin (Drug); Brachytherapy (Radiation); Pelvic radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years |
55; 83; 149; 141 | 0.029 sig |
| SECONDARY Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points |
5; 8; 221; 238; 10; 25 | 0.0008 sig |
| SECONDARY Local Failure Rate |
0.113; 0.166 | 0.096 |
| SECONDARY Tumor Response |
223; 217; 22; 20 | 0.250 |
| SECONDARY Number of Participants Who Died From Any Cause at Various Time Points |
3; 0; 253; 254; 9; 4 | 0.0224 sig |
| SECONDARY Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points |
8; 8; 221; 238; 14; 25 | 0.0227 sig |
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.
Eligibility Criteria
Inclusion Criteria
- diagnosed with cancer of cervix
- tumor that can be measured
- no previous treatment with chemotherapy or radiation for this cancer
- Karnofsky Performance Status Score >=70
- able to give written consent
- willing and able to participate in the study, both during the active treatment and the follow-up period.
Exclusion Criteria
- impairment such as hearing loss from prior cisplatin therapy
- damage to nerves such as being unable to distinguish hot and cold to touch
- used other experimental medication in past 30 days
- lab test results are not within the limits required for this study
- pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
Data sourced from ClinicalTrials.gov (NCT00191100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.