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A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00754078
First received: September 15, 2008
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

The hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.


Condition Intervention Phase
Anal Canal Cancer
 Radiation: Tomotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study to Assess Acute Toxicity and Quality of Life of Patients With Carcinoma of the Anal Canal Receiving Chemotherapy and Radiation Using Helical Tomotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Acute Toxicity and Quality of LIfe [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • colostomy-free survival and/or overall survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Local Recurrence [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: September 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
anal cancer patients treated with tomotherapy and chemotherapy
 Radiation: Tomotherapy
30 fractions of tomotherapy treatment

Detailed Description:

This is a phase II study using tomotherapy for radiation treatment delivery along with concurrent 5-FU/mitomycin C for the treatment of T2-T4 cancer of the anal canal. They hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. This is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. This may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient should have histologically proven primary squamous carcinoma or its variant
  • No history of prior malignancy.
  • Patients must be free of metastatic disease out of pelvis at the time of diagnosis
  • Patients must be at least 18 years of age
  • Performance status 0, 1 or 2 ECOG
  • T stage 2-4, Any N, stage MO
  • Patient should be eligible for concomitant chemotherapy
  • Informed written consent required to participate

Exclusion Criteria:

  • Prior radiation to pelvis
  • Pregnant or lactating
  • prior surgical treatment for anal cancer other than biopsy
  • prior surgical or chemotherapy treatment for anal cancer
  • T1 tumours (2cm) or evidence of distant mets
  • comorbid medical conditions precluding radical treatment at the discretion of oncologist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754078

Contacts
Contact: Kurian J Josepth, MD, FRCPC (780) 432 - 8755 kurianjo@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact     708-432-8755     clinical_trials_cci@cancerboard.ab.ca    
Principal Investigator: Kurian J Joseph, MD, FRCPC            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Kurian J Joseph, MD, FRCPC Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00754078     History of Changes
Other Study ID Numbers: GI-24329
Study First Received: September 15, 2008
Last Updated: April 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
tomotherapy

Additional relevant MeSH terms:
Carcinoma
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013