GOG-0263

Official Title

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Study Purpose

To determine if adding chemotherapy to radiation therapy (CRT) can prevent or lengthen the time to recurrence when compared to radiation therapy (RT) alone.

Diagnosis

Eligibility

Radical Hysterectomy and Pelvic Lymphadenectomy only

Must be registered to the study within 8 weeks following surgery.

Are not eligible if they have had a cancer diagnosis in the previous 5 years, with the exception of non-melanoma skin cancer.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Radiation Therapy (high energy x-rays to kill cancer cells)
• Chemotherapy: cisplatin 
• Lab Biomarker Analysis
• Quality of Life questionnaires
• ARM I: Pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.
• ARM II: Cisplatin IV over 1-2 hours on day 1 and 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.

After completion of study therapy,  follow ups occur every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.