Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 09-0086-CE

NCT ID:

NCT00937248

Start Date:

April 2009

Completion Date:

April 2014

Related Keywords:

  • Rectal Cancer
  • Cone Beam CT in rectal cancer patients
  • Immobilizing rectal cancer patients
  • Image guided radiotherapy in rectal cancer patients
  • Rectal Neoplasms

Name

Location