A phase I II study of external beam radiation, brachytherapy and concurrent chemotherapy in localized cancer of the esophagus (RTOG 92-07): Preliminary toxicity report

摘要: Abstract Purpose : A multi-institutional, prospective study was designed to determine the feasibility and tolerance of external beam irradiation plus concurrent chemotherapy esophageal brachutherapy (EB) in a potentially curable group patients with adenocarcinoma or squamous cell carcinoma esophagus. Methods Materials Planned treatment 50 Gy radiation (25 fractions/5 weeks) followed 2 weeks later by EB [either high dose rate (HDR) 5 Gy, 8, 9, 10, for total 15 low (LDR) 20 week 8]. The protocol revised delete LDR alternative, owing poor accrual, decrease HDR 10 (i.e. 8 9). Chemotherapy given 1, 5, 11 cisplatin 75 mg/m2 5-fluorouracil 1000 mg2/m per 24 h, 96-h infusion. closed January 1995 after 56 had been entered on arm. Six patietns were declared ineligible tumor extension gastroesophageal junction (three patients) involved celiac lymph nodes patients). Of eligible patients, planned 40 respectively. Forty-six (92%) histology, three (6%) adenocarcinoma. Results Life-threatening toxicity treatment-related death occurred 13 (26%) 4 (8%) Treatment-related fistulas (12% overall, 14% starting EB) at 0.5–6.2 months from first day brachytherapy, leading three. fourth secondary renal infection attributed chemotherapy. No correlation found between development fistula location primary tumor, brachytherapy active length applicator diameter. So far, 6 have following EB. other only delivered. Conclusion Thirty-five (70%) able complte beam, EB, least two courses Estimated survival 12 is 48%, an estiamted 11-month median rate. Survival does not appear be significantly different seen only. six 35 completing concern. Based incidence fistulas, we urge extreme caution employing as boost