Radiation Therapy With or Without Chemotherapy In Patients with Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
Recruiting | Phase III
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.
To determine if adding chemotherapy to radiation therapy (CRT) can prevent or lengthen the time to recurrence when compared to radiation therapy (RT) alone.
- 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. Should these have links or explanations?
- 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, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
Key Participation Requirements
19 years and older
Stage Ia, Ib, and IIa cervical cancer
Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma
Radical Hysterectomy and Pelvic Lymphadenectomy only
Must be registered to the study within 8 weeks following surgery.
Patients 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.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.