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

Anal Canal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00754078
• Other study ID #: GI-24329
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: July 4, 2016
• Start date: September 2008
• Est. completion date: October 2016

Study information

• Verified date: July 2016
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 femoral neck and head.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Canal Cancer

Intervention

Radiation:
• Tomotherapy
30 fractions of tomotherapy treatment

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Toxicity and Quality of LIfe		3 months	No
Secondary	colostomy-free survival and/or overall survival		3 and 5 years	No
Secondary	Local Recurrence		3 and 5 years	No