PURPOSE: To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer. METHODS:Patients with fixed cT3 or cT4 or locally recurrent rectal cancer without distant metastases were randomized to either 5 × 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment. RESULTS:49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II. CONCLUSIONS: The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies.
RCT Entities:
PURPOSE: To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer. METHODS:Patients with fixed cT3 or cT4 or locally recurrent rectal cancer without distant metastases were randomized to either 5 × 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment. RESULTS: 49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II. CONCLUSIONS: The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies.
Authors: Robert J Myerson; Benjamin Tan; Steven Hunt; Jeffrey Olsen; Elisa Birnbaum; James Fleshman; Feng Gao; Lannis Hall; Ira Kodner; A Craig Lockhart; Matthew Mutch; Michael Naughton; Joel Picus; Caron Rigden; Bashar Safar; Steven Sorscher; Rama Suresh; Andrea Wang-Gillam; Parag Parikh Journal: Int J Radiat Oncol Biol Phys Date: 2014-03-15 Impact factor: 7.038
Authors: Ewa Kosakowska; Lucyna Pietrzak; Wojciech Michalski; Lucyna Kepka; Wojciech Polkowski; Malgorzata Jankiewicz; Bogumila Cisel; Jacek Krynski; Jacek Zwolinski; Lucjan Wyrwicz; Andrzej Rutkowski; Roman Stylinski; Grzegorz Nawrocki; Rafal Sopylo; Marek Szczepkowski; Wieslaw Tarnowski; Krzysztof Bujko Journal: Rep Pract Oncol Radiother Date: 2020-08-16