A Randomized Study Evaluating Set-up Reproducibility Using Cone Beam CT (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID) in Rectal Cancer Patients Treated With Preoperative Pelvic Radiation Therapy
Rectal cancer accounts for 5% of all cancers diagnosed in Canada for both men and women
between 1995 and 2004 (Public Health agency of Canada _ Health 2004). Preoperative
radiotherapy (RT), with or without chemotherapy, is an accepted treatment for patients with
locally advanced rectal carcinoma followed by surgical resection (Bosset and Horiot 2001;
Sauer, Fietkau et al. 2003; Birgisson, Talback et al. 2005). The current standard treatment
at Princess Margaret Hospital (PMH) is preoperative pelvic radiation therapy to a total dose
of 50 Gy/25 fractions/5 weeks. The total radiation dose is reduced to 45 Gy/25 fractions/5
weeks when there is a concern about the volume of small bowel within the treatment volume.
Radiation therapy is delivered with 5-fluorouracil (5-FU), 225mg/m2/24h, by protracted
venous infusion (PVI) or oral capecitabine, 825 mg/m2 BID for 5 weeks, starting the first
day and completing the day of last day of radiation therapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparing the use of a prone pillow and simple ankle fixation device vs. the use of a CVID for immobilization rectal patients during the course of preoperative radiation therapy using KV CBCT for IGRT.
John Kim, MD
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
UHN REB 09-0086-CE