Radiation Therapy + Cisplatin for Endometrial Cancer

Recruiting at 447 trial locations

Overseen by Jonathan M Feddock

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GOG Foundation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as 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. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Research Team

Jonathan M Feddock

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with recurrent endometrial cancer who've had a hysterectomy and bilateral salpingo-oophorectomy. They should be in good physical condition (GOG status 0-2), have no extrapelvic disease, and could have had prior hormone or chemotherapy finished at least 6 months ago. Excluded are those with other recent cancers, severe heart conditions, previous pelvic radiation, or significant infections.

Inclusion Criteria

My nerve damage does not significantly affect my daily activities.

I have had a stent or tube placed for my blocked ureter before joining the study.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have not had serious heart problems in the last 6 months.

I have a severe infection or septicemia.

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

Treatment Details

Interventions

• 3-Dimensional Conformal Radiation Therapy (Radiation)
• Cisplatin (Alkylating agents)
• Intensity-Modulated Radiation Therapy (Radiation)
• Internal Radiation Therapy (Radiation)

Trial Overview The study compares the effectiveness of radiation therapy alone versus combined with cisplatin in treating recurrent endometrial cancer. It's a phase II trial to see if adding cisplatin improves outcomes. Participants will receive either high-energy x-rays or both x-rays and cisplatin.

Participant Groups

Group I: Arm II (brachytherapy, radiation therapy, cisplatin) Experimental Treatment 4 Interventions

Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.

Group II: Arm I (brachytherapy, radiation therapy) Experimental Treatment 3 Interventions

Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.

3-Dimensional Conformal Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Japan as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in China as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Switzerland as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Who Is Running the Clinical Trial?

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

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