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Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

NCT00191100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2009-08-11

Study results available
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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

  • Cancer of Cervix

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Argentina
  • Bosnia and Herzegovina
  • India
  • Mexico
  • Pakistan
  • Peru
  • Thailand

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191100 on ClinicalTrials.gov