Radiation Therapy + Chemotherapy for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+728 other locations

Overseen bySang 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.

See 15 more

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.

See 6 more

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 OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (cisplatin, EBRT, IMRT)Experimental Treatment6 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 Control5 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: