CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
Gemcitabine +3 moredrug
Likely dose
Gemcitabine and cisplatin (concurrent with pelvic radiation 1.8 Gy/day, 5 days/week for 6 weeks; followed by brachytherapy 30–35 Gy over 1 week; adjuvant arm receives additional gemcitabine/cisplatin)AI-extracted
Key inclusion· 5
  • ✓Diagnosed with cancer of the cervix, stages IIB to IVA
  • ✓Tumor that can be measured
  • ✓No previous treatment with chemotherapy or radiation for this cancer
  • ✓Karnofsky Performance Status ≥70
Key exclusion· 5
  • ✕Prior hearing loss or ototoxicity from cisplatin therapy
  • ✕Peripheral neuropathy (inability to distinguish hot and cold)
  • ✕Use of other experimental medication in past 30 days
  • ✕Lab test results outside acceptable limits for study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00191100
NCT00191100Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Aug 11, 2009

In Brief

A Phase 3 clinical trial evaluating Gemcitabine, Cisplatin, and 2 other interventions for Cancer of Cervix. Completed, enrolled 515 participants across 7 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of Cervix
CountriesArgentina, Bosnia and Herzegovina, India, Mexico, Pakistan, Peru, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMay 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Cisplatindrug

Brachytherapyradiation

Brachytherapy, 30-35 Gy over 1 week

Pelvic radiationradiation

Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks