MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

Overview

The purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented as standard treatment. Surgery is reserved for salvage treatment.

Full Title of Study: “A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2013

Detailed Description

Anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. Prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. The standard of care is radical chemoradiation with 5-fluorouracil and mitomycin C, with surgery reserved for salvage. Intensity modulated radiation therapy (IMRT) is a specialized radiotherapy technique that may be used for anal cancer. IMRT allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. At the Princess Margaret Hospital (PMH) since July 2007, IMRT for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.

Interventions

  • Other: Magnetic Resonance Imaging (MRI)
    • This study involves three imaging sessions (Magnetic Nuclear Resonance -MRI), with one session before radiation therapy and two sessions during radiation therapy (one at 3 weeks of RT; the other during the last week of RT). Each imaging session will last for approximately 45 to 60 minutes.

Arms, Groups and Cohorts

  • MRI Scan

Clinical Trial Outcome Measures

Primary Measures

  • Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI
    • Time Frame: 12 months
  • Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
    • Time Frame: 12 months
  • Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
    • Time Frame: 12 months

Secondary Measures

  • Change with time from start of radiotherapy course in primary tumor dimensions from MRI
    • Time Frame: 12 months
  • Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI
    • Time Frame: 12 months
  • Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region
  • treatment with curative intent
  • patients who are not eligible for chemotherapy and receive IMRT alone are eligible for evaluation
  • primary anal or perianal cancer evaluable on cross-sectional imaging (CT or MRI) scan
  • ECOG performance status of 0, 1, or 2
  • age > 18 years
  • able to provide informed consent

Exclusion Criteria

  • evidence of distant metastasis (M1)
  • prior radiation therapy to the pelvis or contraindication to radiotherapy
  • contraindication to MRI imaging
  • known allergy to intravenous Gadolinium
  • renal insufficiency (serum creatinine greater than 150)
  • serious claustrophobia
  • cardiac pacemaker
  • hip prosthesis
  • major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of imaging study

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Collaborator
    • Princess Margaret Hospital, Canada
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Dinniwell, MD, Principal Investigator, University Health Network, Princess Margaret Hospital

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