Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study
Patients with unresectable primary rectal cancer or with unresectable local recurrence
without distant metastases are randomly allocated to control or experimental arm. The
preoperative treatment in the control arm is conventionally fractionated chemoradiation with
50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu,
leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5
days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4.
Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks
from the last dose of fluorouracil or radiation. The study hypothesis is that the
short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10%
increase of the rate of R0 resection compared to preoperative chemoradiation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The rate of patients with R0 resection
Surrogate endpoint available immediatly after surgery
Krzysztof Bujko, Prof.
Roentgena 5, 02-781 Warsaw, Poland
Poland: Ministry of Science and Higher Education