MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anal Cancer Patients Perianal Patients |
Other: Magnetic Resonance Imaging (MRI) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer |
- Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change with time from start of radiotherapy course in primary tumor dimensions from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with anal canal or 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
Contacts and Locations| Contact: Robert Dinniwell, MD | 416 946 4501 ext 4662 | robert.dinniwell@rmp.uhn.on.ca |
| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Robert Dinniwell, MD 416 946 4501 ext 4662 Robert.Dinniwell@rmp.uhn.on.ca | |
| Principal Investigator: | Robert Dinniwell, MD | University Health Network, Princess Margaret Hospital |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01053923 History of Changes |
| Other Study ID Numbers: | UHN REB 09-0695-CE |
| Study First Received: | January 21, 2010 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Perianal Cancer Anal Cancer MRI scan |
Additional relevant MeSH terms:
|
Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013