Randomized Multicentre Phase III Study of Short Course Radiation Therapy Followed by Prolonged Pre-operative Chemotherapy and Surgery in Primary High Risk Rectal Cancer Compared to Standard Chemoradiotherapy and Surgery and Optional Adjuvant Chemotherapy.
Patients will be randomized between an experimental group (arm B) in which short course 5 x
5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine
and oxaliplatin) and surgery and a control group (arm A) with long course chemoradiotherapy
followed by surgery. In arm A adjuvant chemotherapy is allowed according to the local
protocol of the institution. In both groups the rectal tumour will be removed by TME surgery
or more extensive surgery if required because of tumour extent.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival will be computed as the time between randomization and either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. Patients lost to follow-up will be censored the last date of patient visit.Survival curves for disease-free survival after 3 years of follow-up will be constructed using the method of Kaplan and Meier.
B. van Etten, Md, PhD
University Medical Center Groningen, Department of Surgery, Groningen, The Netherlands
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)