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

AHS Cancer Control Alberta

Status and phase

Unknown

Phase 2

Conditions

Anal Canal Cancer

Treatments

Radiation: Tomotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00754078

GI-24329

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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