Randomized trial of postoperative adjuvant therapy in XXXX to define the optimal sequence of chemotherapy and radiotherapy: a preliminary report.

@entity5 @entity1 @entity1487 @entity4181
PURPOSE: We conducted a prospective randomized trial to define the optimal sequence of chemotherapy and radiotherapy of postoperative adjuvant treatment in @entity5 . @entity1 AND METHODS: Three hundred eight @entity1 were enrolled onto the study. We randomly assigned 155 to arm I (early radiotherapy group) and 153 to arm II (late radiotherapy group). Treatment included eight cycles of chemotherapy at 4-week intervals and pelvic radiotherapy of 45 Gy in 25 fractions. Radiotherapy started on day 1 of the first chemotherapy cycle in arm I and on day 1 of the third chemotherapy cycle in arm II. The chemotherapy regimen consisted of @entity1487 375 mg/m(2)/d and @entity4181 20 mg/m(2)/d. Chemotherapy was administered for 3 days per cycle in two cycles during the period of radiotherapy and for 5 days per cycle in the remaining six cycles. RESULTS: Twenty @entity1 in arm I and 14 in arm II were not eligible. We included 274 @entity1 in the analysis. With a median follow-up of 37 months for surviving @entity1 , disease-free survival was significantly prolonged in arm I compared with arm II (81% v. 70% at 4 years; P =.043). Twenty-three recurrences occurred in arm I and 38 in arm II (P =.047). Overall survival was not significantly different between arms I and II (84% v. 82% at 4 years; P =.387). CONCLUSION: Early radiotherapy with concurrent chemotherapy after resection of @entity5 demonstrated a statistically significant advantage for disease-free survival compared with late radiotherapy with chemotherapy.
