Chemotherapy + Radiation for Uterine Cancer

Recruiting in Palo Alto (17 mi)

+716 other locations

Overseen by Daniela E Matei

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?

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.

Research Team

Daniela E Matei

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with stage I-IVA endometrial cancer who've had surgery including hysterectomy and possibly lymph node sampling. They must have certain blood cell counts, liver function within normal limits, no prior pelvic/abdominal radiation or chemotherapy for endometrial cancer, no other active cancers in the last five years (except non-melanoma skin cancer), and not exceed a tumor size of 2 cm after surgery.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1,500/mcl

Platelet count >= 100,000/mcl

Alkaline phosphatase =< 2.5 times ULN

Exclusion Criteria

I have no active cancer other than non-melanoma skin cancer in the last 5 years.

I have been diagnosed with carcinosarcoma.

My only extra-uterine cancer is not clear cell or papillary serous.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Cisplatin (Alkylating agents)
• Internal Radiation Therapy (Radiation)
• Paclitaxel (Taxane)
• Radiation Therapy (Radiation)

Trial Overview The study compares carboplatin and paclitaxel chemotherapy with or without additional cisplatin and radiation therapy to see which is more effective at treating endometrial cancer post-surgery. The goal is to determine if adding cisplatin and radiation improves outcomes.

Participant Groups

Group I: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin) Experimental Treatment 6 Interventions

Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (paclitaxel and carboplatin) Active Control 3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

Dr. Larry J. Copeland

Gynecologic Oncology Group

Chief Medical Officer since 2017

MD from The Ohio State University

Dr. Thomas J. Herzog

Gynecologic Oncology Group

Chief Executive Officer since 2023

MD from University of Cincinnati

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School