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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00937248
First received: July 8, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Rectal Cancer
Device: prone pillow and simple ankle fixation device
Device: Customized Vacuum Immobilization Device (CVID)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937248

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Kim, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00937248     History of Changes
Other Study ID Numbers: UHN REB 09-0086-CE
Study First Received: July 8, 2009
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Cone Beam CT in rectal cancer patients
Immobilizing rectal cancer patients
Image guided radiotherapy in rectal cancer patients

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014