Extended-Field Irradiation and Intracavitary Brachytherapy Combined With Cisplatin Chemotherapy for Cervical Cancer With Positive Para-Aortic or High Common Iliac Lymph Nodes: Results of ARM 1 of RTOG 0116
- Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (United States)
- RTOG Statistical Section, Philadelphia, PA (United States)
- Department of Gynecologic Oncology, M. D. Anderson Cancer Center, Houston, TX (United States)
- Department of Radiology, M. D. Anderson Cancer Center, Houston, TX (United States)
- Department of Radiation Oncology, University of Utah, Salt Lake City, UT (United States)
- Department of Radiation Oncology, Albert Einstein Medical Center, Philadelphia, PA (United States)
- Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States)
- Department of Radiation Oncology, M. D. Anderson Cancer Center, Houston, TX (United States)
- Department of Radiation Oncology, Wake Forest University, Winston Salem, NC (United States)
Purpose: The Radiation Therapy Oncolology Group (RTOG) 0116 trial was designed to test the ability of Amifostine to reduce the toxicity of combined chemotherapy with extended-field radiotherapy and brachytherapy (Part 2), after first determining the toxicity rate for the regimen without Amifostine (Part 1). This manuscript reports the results of Part 1. Methods and Materials: Eligibility included patients with cervical carcinoma and high common iliac or para-aortic metastasis. Patients received extended-field radiotherapy to 45 Gy (1.8 Gy/fraction) with intracavitary irradiation. The final point A dose was 85 Gy LDR equivalent. Use of HDR was allowed. The positive para-aortic and high common iliac nodes were boosted to 54 to 59.4 Gy. Cisplatin (40 mg/m{sup 2}) was delivered weekly during external beam and once with brachytherapy. The primary endpoint of Part 1 was acute Grade 3/4 toxicity, excluding Grade 3 leukopenia. Results: A total of 26 eligible patients were entered between August 1, 2000, and Decemeber 3, 2003. Of these, 21 had para-aortic metastasis (15 also had high common iliac involvement), and 5 had high common iliac involvement only. The median follow-up was 17.1 months (range, 1.8-38.6 months) for all patients and 21.7 months (range, 11.4-38.6 months) for alive patients. The acute Grade 3/4 toxicity rate, excluding Grade 3 leukopenia was 81%. Late Grade 3/4 toxicity was 40%. Eight patients underwent surgery for complications. Sixteen (62%) patients had a complete response for both local and nodal disease. The complete local response was 92%, the complete overall nodal response rate was 62% and the regional and para-aortic nodal response rates were 60% and 71% respectively. Estimated disease-free and overall survival at 18 months are 46% and 60%. Conclusions: Extended field and intracavitary irradiation with cisplatin for para-aortic or high common iliac metastasis from cervical cancer is associated with significant acute and late toxicity.
- OSTI ID:
- 20953559
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 68, Issue 4; Other Information: DOI: 10.1016/j.ijrobp.2007.01.026; PII: S0360-3016(07)00134-4; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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