A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

Inclusion Criteria: All of the following must apply: Pathologically documented and clinically resectable adenocarcinoma of the rectum. The patient must be considered by the surgeon to be suitable for a curative resection. The patient must be considered by the radiation oncologist to have no contraindication to pre-operative radiotherapy. Clinical T3 stage tumour on endorectal ultrasound or MRI. When endorectal ultrasound cannot be performed satisfactorily due to a technical reason, such as stenosis or proximity of the tumour, and MRI is not available, infiltration of perirectal fat on CT scan is also acceptable. Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy. ECOG performance status 0, 1 or 2. Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet count at least 100 x 109/L. Adequate liver function with bilirubin and alanine aminotransferase (ALT) <= 1.5 times the upper limit of normal. Adequate renal function with serum creatinine <= 1.5 times the upper limit of normal. Accessibility for treatment and follow-up. Written informed consent. Exclusion Criteria: None of the following must apply: Evidence of distant metastases. Recurrent rectal cancer. Unstable cardiac disease or clinically significant active infection. Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma in situ of the cervix. Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures. Contraindication to insertion of a suitable indwelling venous catheter e.g. implantable central venous device (infuse-a-port), Hickman catheter or peripherally inserted central catheter. Prior pelvic or abdominal radiotherapy.