Status:
UNKNOWN
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
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Anal Canal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 fem...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00754078
Start Date
September 1 2008
End Date
October 1 2016
Last Update
July 6 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2