Prospective Multi-Institutional Study of Definitive Radiotherapy With High-Dose-Rate Intracavitary Brachytherapy in Patients With Nonbulky (<4-cm) Stage I and II Uterine Cervical Cancer (JAROG0401/JROSG04-2)
- Department of Radiology, Graduate School of Medical Science, University of Ryukyus, Okinawa (Japan)
- Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba (Japan)
- Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan)
- Gunma University Heavy Ion Medical Center, Maebashi (Japan)
- Department of Radiology, Saitama Cancer Center, Saitama (Japan)
- Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan)
- Department of Radiology, National Shikoku Cancer Center, Ehime (Japan)
- Department of Radiation Oncology, Saku Central Hospital, Saku (Japan)
- Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan)
- Department of Radiology, Saga University, Saga (Japan)
- Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan)
- Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan)
- Proton Medical Research Center and Tsukuba University, Tsukuba (Japan)
- Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita, Osaka (Japan)
- Department of Radiation Oncology, Cancer Institute Hospital, Tokyo (Japan)
- Radiation Oncology Division, National Cancer Center Hospital, Tokyo (Japan)
- Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan)
- Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan)
- Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo (Japan)
Purpose: To determine the efficacy of a definitive radiotherapy protocol using high-dose-rate intracavitary brachytherapy (HDR-ICBT) with a low cumulative dose schedule in nonbulky early-stage cervical cancer patients, we conducted a prospective multi-institutional study. Methods and Materials: Eligible patients had squamous cell carcinoma of the intact uterine cervix, Federation of Gynecologic Oncology and Obstetrics (FIGO) stages Ib1, IIa, and IIb, tumor size <40 mm in diameter (assessed by T2-weighted magnetic resonance imaging), and no pelvic/para-aortic lymphadenopathy. The treatment protocol consisted of whole-pelvis external beam radiotherapy (EBRT) of 20 Gy/10 fractions, pelvic EBRT with midline block of 30 Gy/15 fractions, and HDR-ICBT of 24 Gy/4 fractions (at point A). The cumulative biologically effective dose (BED) was 62 Gy{sub 10} ({alpha}/{beta} = 10) at point A. The primary endpoint was the 2-year pelvic disease progression-free (PDPF) rate. All patients received a radiotherapy quality assurance review. Results: Between September 2004 and July 2007, 60 eligible patients were enrolled. Thirty-six patients were assessed with FIGO stage Ib1; 12 patients with stage IIa; and 12 patients with stage IIb. Median tumor diameter was 28 mm (range, 6-39 mm). Median overall treatment time was 43 days. Median follow-up was 49 months (range, 7-72 months). Seven patients developed recurrences: 3 patients had pelvic recurrences (2 central, 1 nodal), and 4 patients had distant metastases. The 2-year PDPF was 96% (95% confidence interval [CI], 92%-100%). The 2-year disease-free and overall survival rates were 90% (95% CI, 82%-98%) and 95% (95% CI, 89%-100%), respectively. The 2-year late complication rates (according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer of Grade {>=}1) were 18% (95% CI, 8%-28%) for large intestine/rectum, 4% (95% CI, 0%-8%) for small intestine, and 0% for bladder. No Grade {>=}3 cases were observed for genitourinary/gastrointestinal late complications. Conclusions: These results suggest that definitive radiotherapy using HDR-ICBT with a low cumulative dose schedule (BED, 62 Gy{sub 10} at point A) can provide excellent local control without severe toxicity in nonbulky (<4-cm) early-stage cervical cancer.
- OSTI ID:
- 22055948
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 82, Issue 1; Other Information: Copyright (c) 2012 Elsevier Science B.V., Amsterdam, The 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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