Cone Beam Computed Tomography (CT) (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID)

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: Customized Vacuum Immobilization Device (CVID); Device: prone pillow and simple ankle fixation device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Patient randomized to be immobilized using a prone pillow and simple ankle fixation device with a CVID.	Device: 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: Standard Arm; Patient randomized to be immobilized using a prone pillow and simple ankle fixation device without a CVID	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: John Kim, MD, University Health Network, Princess Margaret Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimated): July 10, 2009

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cone Beam CT in rectal cancer patients; Immobilizing rectal cancer patients; Image guided radiotherapy in rectal cancer patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: UHN REB 09-0086-CE