A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer
19 Years
N/A
Both
Anal Cancer Patients, Perianal Patients
Trial Information
A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Robert Dinniwell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 09-0695-CE
NCT ID:
NCT01053923
Start Date:
December 2009
Completion Date:
March 2013
Related Keywords:
- Anal Cancer Patients
- Perianal Patients
- Perianal Cancer
- Anal Cancer
- MRI scan
- Anus Neoplasms
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