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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2016-10-31

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.

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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.

Conditions

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Anal Canal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

anal cancer patients treated with tomotherapy and chemotherapy

Group Type OTHER

Tomotherapy

Intervention Type RADIATION

30 fractions of tomotherapy treatment

Interventions

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Tomotherapy

30 fractions of tomotherapy treatment

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No