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)

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 10 (α/β = 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 10 at point A) can provide excellent local control without severe toxicity in nonbulky (