tailieunhanh - Báo cáo khoa học: "Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Radiation Oncology cung cấp cho các bạn kiến thức về ngành y đề tài: Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer. | Velenik et al. Radiation Oncology 2010 5 88 http content 5 1 88 RADIATION ONCOLOGY RESEARCH Open Access Long-term results from a randomized phase II trial of neoadjuvant combined-modality therapy for locally advanced rectal cancer Vaneja Velenik Irena Oblak Franc Anderluh Abstract Background This study evaluated the effectiveness and safety of preoperative chemoradiotherapy with capecitabine in patients with locally advanced resectable rectal cancer. This report summarizes the results of the phase II study together with long-term 5-year follow-up. Methods Between June 2004 and January 2005 57 patients with operable clinical stage II-III adenocarcinoma of the rectum entered the study. Radiation dose was 45 Gy delivered as 25 fractions of Gy. Concurrent chemotherapy with oral capecitabine 825 mg m2 twice daily was administered during radiotherapy and at weekends. Surgery was scheduled 6 weeks after the completion of the chemoradiotherapy. Patients received four cycles of postoperative chemotherapy comprising either capecitabine 1250 mg m2 bid days 1-14 every 3 weeks or bolus . 5-fluorouracil 425 mg m2 day and leucovorin 20 mg m2 day days 1-5 every 4 weeks choice was at the oncologist s discretion . Study endpoints included complete pathological remission proportion of R0 resections and sphincter-sparing procedures toxicity survival parameters and long-term 5-year rectal and urogenital morbidity assessment. Results One patient died after receiving 27 Gy because of a pulmonary embolism. Fifty-six patients completed radiochemotherapy and had surgery. Median follow-up time was 62 months. No patients were lost to follow-up. R0 resection was achieved in 55 patients. A complete pathological response was observed in 5 patients T- N-and overall downstaging rates were 40 and respectively. The 5-year overall survival rate recurrence-free survival and local control was 95 CI 95 CI and 95 CI .

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