Preoperative Combined Radiation and Chemotherapy - Rectal Cancer
Preoperative Combined Radiation and Chemotherapy - Rectal Cancer
There is no established standard preoperative treatment in rectal cancer. Two large
 randomized studies in North America closed from lack of accrual; therefore the only method of
 assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds
 on the experience at PMH gained in two previous studies which demonstrated a lower than
 expected toxicity with concurrent 5FU infusion and external radiotherapy. The current
 standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion
 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve
 the response rate, but may also increase toxicity. It is proposed to increase the dose of
 radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity
 and complete remission rate.
Inclusion Criteria:

 -  Biopsy proven adenocarcinoma of the rectum

 -  Performance status <2 (ECOG, appendix II)

 -  Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis

 Exclusion Criteria:

 -  Prior pelvic irradiation

 -  Inflammatory bowel disease

 -  Evidence of distant metastasis

 -  Performance status >2