This trial is active, not recruiting.

Condition rectal cancer
Treatments prone pillow and simple ankle fixation device, customized vacuum immobilization device (cvid)
Sponsor University Health Network, Toronto
Start date April 2009
End date February 2017
Trial size 20 participants
Trial identifier NCT00937248, UHN REB 09-0086-CE


This study is designed to investigate whether or not the use of a customized vacuum immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative pelvic radiation therapy improves the positional stability of patients during each radiation treatment. This question is more relevant now in the era of image-guided radiation therapy (IGRT). Using state of the art IGRT technologies such as cone beam CT (CBCT) scanning, assessments of the accuracy of treatment delivery can be made during a course of radiation therapy allowing for patient set-up corrective strategies to be implemented. The use of CBCT scanning may minimize any potential benefit of of a CVID if the patient's pretreatment position can be corrected prior to treatment and our current immobilization strategy results in a stable patient position. While it is seemingly intuitive to assume that the use of CVID results in better patient stability, there is actually little data to support this.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Patient randomized to be immobilized using a prone pillow and simple ankle fixation device with a CVID.
customized vacuum immobilization device (cvid)
This device is a bean bag like cushion that is placed from the abdomen to the thighs. When a patient is comfortably lying on this device, air within the bag is suctioned out resulting in an impression or cast of a patient.
(Active Comparator)
Patient randomized to be immobilized using a prone pillow and simple ankle fixation device without a CVID
prone pillow and simple ankle fixation device
Patients will lie face down (prone) on a soft cushion made of foam under their face and upper chest. Additionally, there is a foam support placed at the ankles.

Primary Outcomes

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.
time frame: 2 years

Secondary Outcomes

quantify interfractional set-up displacements using either of the two devices;determine a standard planning target volume margin; evaluate the role of soft-tissue image matching for IGRT using CBCT.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Any rectal cancer patient who is to receive a 5 week course of preoperative pelvic radiation therapy with or without concurrent chemotherapy - Prone treatment position - Age 18 years or older - Informed consent Exclusion Criteria: - Inability to provide informed consent - Inability to tolerate treatment in the prone position - Pregnancy - Patients with unilateral or bilateral metallic total hip replacements

Additional Information

Official title 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
Principal investigator John Kim, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.