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Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

NCT00006011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 659

Last updated 2015-05-19

Study results available
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Summary

Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.

Conditions

  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
  • Endometrial Serous Adenocarcinoma
  • Stage III Uterine Corpus Cancer

Interventions

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Cisplatin

Given IV

BIOLOGICAL

Filgrastim

Given SC

BIOLOGICAL

Pegfilgrastim

Given SC

DRUG

Paclitaxel

Given IV

Sponsors & Collaborators

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Howard Homesley · Gynecologic Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2010-03-31

Countries

  • United States

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 NCT00006011 on ClinicalTrials.gov