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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

NCT00262821 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2019-07-23

Study results available
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Summary

This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Stage IB Cervical Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer

Interventions

DRUG

cisplatin

Given IV

DRUG

tirapazamine

Given IV

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Gynecologic Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Paul DiSilvestro · Gynecologic Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00262821 on ClinicalTrials.gov