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Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

NCT00942357 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 813

Last updated 2021-10-19

Study results available
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Summary

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Conditions

  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Stage IA Uterine Corpus Cancer AJCC v7
  • Stage IB Uterine Corpus Cancer AJCC v7
  • Stage II Uterine Corpus Cancer AJCC v7
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage IIIC Uterine Corpus Cancer AJCC v7
  • Stage IVA Uterine Corpus Cancer AJCC v7

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

RADIATION

Internal Radiation Therapy

Undergo brachytherapy

DRUG

Paclitaxel

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Daniela E Matei · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-29
Primary Completion
2016-02-15
Completion
2024-07-28

Countries

  • United States
  • Canada
  • South Korea

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 NCT00942357 on ClinicalTrials.gov