Radiation Therapy + Chemotherapy for Cervical Cancer

Recruiting at 728 trial locations

Overseen by Sang Y Ryu

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 radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays 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 chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

Research Team

Sang Y Ryu

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with stage I-IIA cervical cancer who had surgery. Eligible participants must have certain types of cervical cancer, adequate organ function, and no severe infections or other cancers in the last five years. They should be able to complete the study and follow-up.

Inclusion Criteria

Patients who have met the pre-entry requirements

My cervical cancer was initially treated with surgery to remove the uterus and pelvic lymph nodes.

The condition has spread deeply into the third layer.

Exclusion Criteria

I have a severe infection or septicemia.

My cancer has spread to areas near the uterus or I have positive surgical margins.

I have a blockage in my intestines or bleeding in my digestive tract.

Treatment Details

Interventions

• Cisplatin (Platinum-based Chemotherapy)
• External Beam Radiation Therapy (Radiation)
• Intensity-Modulated Radiation Therapy (Radiation)
• Laboratory Biomarker Analysis (Other)
• Quality-of-Life Assessment (Other)
• Questionnaire Administration (Other)

Trial Overview The trial is testing if adding chemotherapy (Cisplatin) to radiation therapy improves outcomes compared to radiation alone after surgery in treating early-stage cervical cancer. It's a phase III study where patients are randomly assigned to one of the treatments.

Participant Groups

Group I: Arm II (cisplatin, EBRT, IMRT) Experimental Treatment 6 Interventions

Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (EBRT, IMRT) Active Control 5 Interventions

Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+