NCT00937248

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

14.1 years

First QC Date

July 8, 2009

Last Update Submit

October 25, 2023

Conditions

Rectal Cancer

Keywords

Cone Beam CT in rectal cancer patientsImmobilizing rectal cancer patientsImage guided radiotherapy in rectal cancer patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Interventional

EXPERIMENTAL

Patient randomized to be immobilized using a prone pillow and simple ankle fixation device with a CVID.

Device: Customized Vacuum Immobilization Device (CVID)

Standard Arm

ACTIVE COMPARATOR

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

Interventions

prone pillow and simple ankle fixation deviceDEVICE

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.

Standard Arm
Customized Vacuum Immobilization Device (CVID)DEVICE

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.

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent
  • Inability to tolerate treatment in the prone position
  • Pregnancy
  • Patients with unilateral or bilateral metallic total hip replacements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • John Kim, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 10, 2009

Study Start

April 1, 2009

Primary Completion

April 21, 2023

Study Completion

April 21, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

CA(1)