MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

Anal Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01053923
• Other study ID #: UHN REB 09-0695-CE
• Status: Withdrawn
• Phase: N/A
• First received: January 21, 2010
• Last updated: June 11, 2013
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Cancer Patients
• Anus Neoplasms
• Perianal Patients

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI		12 months	No
Primary	Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI		12 months	No
Primary	Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI		12 months	No
Secondary	Change with time from start of radiotherapy course in primary tumor dimensions from MRI		12 months	No
Secondary	Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI		12 months	No
Secondary	Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI		12 months	No