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

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.

Study Overview

• Status: Unknown
• Conditions: Anal Canal Cancer
• Intervention / Treatment: Radiation: Tomotherapy

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 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; anal cancer patients treated with tomotherapy and chemotherapy	Radiation: Tomotherapy; 30 fractions of tomotherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute Toxicity and Quality of LIfe	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
colostomy-free survival and/or overall survival	3 and 5 years
Local Recurrence	3 and 5 years

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Investigators: Principal Investigator: Kurian J Joseph, MD, FRCPC, AHS Cancer Control Alberta

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: September 15, 2008
• First Submitted That Met QC Criteria: September 15, 2008
• First Posted (Estimate): September 17, 2008

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: tomotherapy
• Other Study ID Numbers: GI-24329