Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

Recruiting in Palo Alto (17 mi)

+64 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gynecologic Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: 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. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

Research Team

Higinia R. Cardenes, MD, PhD

Principal Investigator

Indiana University Melvin and Bren Simon Cancer Center

Aaron H. Wolfson, MD

Principal Investigator

University of Miami Sylvester Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)

Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port

Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study

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