Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients with High-Risk Early-Stage Cervical Cancer after Radical Hysterectomy.
Recruiting | Phase III
Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy
To determine if adding chemotherapy after the usual treatment of chemotherapy and radiation therapy will prevent or lengthen the time to recurrence when compared to the usual treatment of chemotherapy and radiation therapy alone.
- Radiation Therapy (high energy x-rays to kill cancer cells)
- Chemotherapy: cisplatin
- Lab Biomarker Analysis
- Quality of Life questionnaires
- ARM I: Standard radiation therapy to the pelvis once daily 5 days a week for 5-6 weeks, and cisplatin IV over 1 hour once weekly for 6 weeks.
- NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.
- ARM II: Chemoradiotherapy as in arm I. Then 4-6 weeks after the completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each 21-day cycle. Treatment repeats every 21 days for 4 cycles 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 IA2, IB, or IIA disease with any/all of the following high-risk features after surgery:
- Positive pelvic nodes
- Positive parametrium
- Positive para-aortic nodes
Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma
- Radical Hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
- No prior chemotherapy for the current cervical cancer
- Prior chemotherapy for a different cancer is allowed
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
- Patients are not eligible if they have had a cancer diagnosis in the previous 3 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.