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 - Full Text View

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00754078

Purpose

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

Condition	Intervention	Phase
Anal Canal Cancer	Radiation: Tomotherapy	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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 Alberta Cancer Board:

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:	September 2010
Estimated Primary Completion Date:	September 2010 (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
Edmonton, Alberta, Canada, T6G 1Z2

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Kurian J Joseph, MD, FRCPC

Alberta Cancer Board

More Information

Responsible Party:	Cross Cancer Institute ( Dr. Kurian J Joseph )
Study ID Numbers:	GI-24329
Study First Received:	September 15, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00754078
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

tomotherapy

Study placed in the following topic categories:

Quality of Life
Carcinoma

ClinicalTrials.gov processed this record on January 13, 2009