MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Anal Cancer Patients; Perianal Patients
• Intervention / Treatment: Other: Magnetic Resonance Imaging (MRI)

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with anal canal or perianal cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI Scan	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Robert Dinniwell, MD, University Health Network, Princess Margaret Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Anal Cancer; Perianal Cancer; MRI scan
• 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; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: UHN REB 09-0695-CE