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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754078
First Posted: September 17, 2008
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Acute Toxicity and Quality of LIfe [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • colostomy-free survival and/or overall survival [ Time Frame: 3 and 5 years ]
  • Local Recurrence [ Time Frame: 3 and 5 years ]

Enrollment: 58
Study Start Date: September 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754078


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Kurian J Joseph, MD, FRCPC AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00754078     History of Changes
Other Study ID Numbers: GI-24329
First Submitted: September 15, 2008
First Posted: September 17, 2008
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by AHS Cancer Control Alberta:
tomotherapy