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
18 Years
N/A
Both
Anal Canal Cancer
Trial Information
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 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute Toxicity and Quality of LIfe
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Kurian J Joseph, MD, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Alberta Health Services
Authority:
Canada: Health Canada
Study ID:
GI-24329
NCT ID:
NCT00754078
Start Date:
September 2008
Completion Date:
April 2014
Related Keywords:
- Anal Canal Cancer
- tomotherapy
- Carcinoma
- Anus Neoplasms
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