Prospective Randomised Trial Of Extended Chemotherapy During The Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer

Interventions: This study will be a prospective randomised controlled trial comparing standard preoperative chemoradiotherapy followed by a wait period without chemotherapy (herein after called standard chemoradiotherapy (SCRT)) with standard chemoradiotherapy followed by a wait period with chemotherapy (hereinafter called extended chemoradiotherapy (XCRT)
Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. Full blood count and MBA20 will be performed weekly during chemoradiotherapy. For patients on standard arm (SCRT), no further preoperative chemotherapy is planned. Patients on the investigational arm will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15). Fullblood count and MBA20 will be performed prior to each chemotherapy cycle. The wait period before surgery will be a standardised 10 weeks after completion of radiotherapy on both arms of the study
Primary outcome(s): The primary outcomes of this study are complete clinical and complete pathological response at the time of surgical management of rectal carcinoma. These are very simply determined as outlined above. The investigators believe this study can be completed very readily within a realistic time frame. Based on the expected response rates for SCRT (25%) and the recently published data on XCRT (65%) and assuming an alpha of 0.05 and a 90% power, a total of 50 patients (25 in each group) would be required.[At the time of surgical management of rectal carcinoma]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Type of endpoint: Efficacy