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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anal Canal Cancer

Intervention / Treatment
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* Radiation: Tomotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>anal cancer patients treated with tomotherapy and chemotherapy | Radiation: Tomotherapy<br>* 30 fractions of tomotherapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity and Quality of LIfe |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colostomy-free survival and/or overall survival |  | 3 and 5 years | 
| Local Recurrence |  | 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tomotherapy