Phase II study of concomitant chemoradiotherapy with local hyperthermia and metronidazole for locally advanced fixed rectal cancer

摘要: Aim Locally advanced fixed T4 rectal cancer has a poor prognosis and no standard treatment strategy. The aim of this study was to investigate the safety efficacy neoadjuvant chemoradiotherapy using hypofractionated radiotherapy combined with local hyperthermia, capecitabine, oxaliplatin metronidazole. Method Radiotherapy given total dose 40 Gy in 10 fractions. Capecitabine 650 mg/m2 twice day on days 1−22 intravenous 50 mg/m2 administered 3, 17. Local 41−45°C for 60 min, performed 8, 10, 15 Metronidazole 10 g/m2 per rectum 8 15. Surgery carried out within 6−8 weeks after treatment. primary end-point R0 resection rate. Secondary end-points included 2-year disease-free survival, overall recurrence rate, grade III−IV tumour regression (Dworak) toxicity. Results From July 2006 February 2011, 64 previously untreated patients were enrolled. 59 (92.2%). Five (7.8%) remained inoperable. Seven (10.9%) had IV 30 (46.9%) III regression. main toxic events diarrhoea (15.6%, n = 10), vomiting (3.1%, n = 2), proctitis n = 2) skin reaction (1.6%, n = 1). Only one (1.6%) patient vomiting. median follow-up 24.9 months. Two-year survival 91% 83%. Conclusion Hyperthermia chemotherapy produce radiosensitization locally is followed by high toxicity comparable regimens.