Overview

This trial is active, not recruiting.

Condition anal canal cancer
Treatment tomotherapy
Phase phase 2
Sponsor AHS Cancer Control Alberta
Start date September 2008
End date October 2016
Trial size 58 participants
Trial identifier NCT00754078, GI-24329

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
anal cancer patients treated with tomotherapy and chemotherapy
tomotherapy
30 fractions of tomotherapy treatment

Primary Outcomes

Measure
Acute Toxicity and Quality of LIfe
time frame: 3 months

Secondary Outcomes

Measure
colostomy-free survival and/or overall survival
time frame: 3 and 5 years
Local Recurrence
time frame: 3 and 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Kurian J Joseph, MD, FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.