MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

NCT ID: NCT01053923

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

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.

Conditions

Anal Cancer Patients; Perianal Patients

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

MRI Scan

Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dinniwell, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Other Identifiers

UHN REB 09-0695-CE

Identifier Type: -

Identifier Source: org_study_id