MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Cancer Patients, Perianal Patients

Intervention / Treatment
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* Other: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI Scan<br> | Other: Magnetic Resonance Imaging (MRI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perianal Cancer, Anal Cancer, MRI scan