Radiation Therapy + Cisplatin for Endometrial Cancer

Recruiting at 447 trial locations

Age: Any Age

Sex: Female

Trial Phase: Phase 2

Sponsor: GOG Foundation

Disqualifiers: Extrapelvic disease, Prior irradiation, Severe infection, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

165 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo external-beam radiotherapy (EBRT) to the pelvis daily for 5 weeks. In Arm II, participants also receive cisplatin intravenously on specified days.

5 weeks

Daily visits for EBRT, additional visits for cisplatin administration

Brachytherapy

Participants undergo intracavitary or interstitial brachytherapy following EBRT. IMRT boost is allowed for certain patients.

Following EBRT

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every month for 3 months, then every 3 months for 2 years, and every 6 months for 3 years.

5 years

Treatment Details

Interventions

• 3-Dimensional Conformal Radiation Therapy
• Cisplatin
• Intensity-Modulated Radiation Therapy
• Internal Radiation Therapy

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 United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in European Union as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+