MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

This study has been withdrawn prior to enrollment.
(Patient eligibility has limited accrual and patient sample has changed with the change in referral patients.)
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01053923
First received: January 21, 2010
Last updated: June 11, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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
Study Population

Patients with anal canal or perianal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053923

Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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: June 11, 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
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014