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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre randomised trial comparing long course (LC) preoperative chemoradiation with short course (SC) preoperative radiotherapy for patients with localised T3 rectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborators: Australasian Gastro-Intestinal Trials Group; Colorectal Surgical Society of Australasia (CSSA); Royal Australasian College of Surgeons (RACS)

Criteria

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.