Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00426504
First received: January 23, 2007
Last updated: July 25, 2007
Last verified: July 2007
  Purpose

Historically, patients with stage III and IV head and neck cancer have been treated with surgery and/or radiation therapy. Based on the results of recent clinical trials, in patients not able to undergo surgery, chemotherapy with radiation therapy has been adopted as the current standard of care. The chemo-radiation approach, however, entails a significant increase in treatment-related toxicity, limiting the extent to which this treatment can be offered to patients. In this trial, the ability of a new form of radiation therapy delivery called IMRT will be evaluated for its ability to reduce the amount of radiation-induced toxicity.


Condition Intervention Phase
Cancer
Procedure: Helical tomotherapy IMRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Helical Tomotherapy Intensity Modulated Radiotherapy:A Phase I/II Pilot Study to Determine the Toxicity Profile, Pattern of Failures and Quality of Life of Patients With Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 1) To determine the toxicity profile of patients with head and neck cancer treated with helical tomotherapy-IMRT

Secondary Outcome Measures:
  • 1) To compare the dose distributions generated by HT-IMRT with those generated using three-dimensional conformal radiation, 2) To determine the pattern of relapse in the primary site and neck within the first 2 years following treatment, 3) To access the

Estimated Enrollment: 80
Study Start Date: November 2006
Estimated Study Completion Date: June 2010
Detailed Description:

The mechanisms of action to explain the radiation-induced toxic effects resulting from the more aggressive radiation therapy treatments of head and neck cancer include the additive and synergistic increase in mucositis from the combination of chemotherapy and radiotherapy. The severe toxicity associated with more aggressive radiation therapy treatments for locoregional head and neck cancer limits the extent to which these treatments can be offered since many patients present with nutritional deficiencies and consequent general debility. Intensity Modulated Radiotherapy (IMRT) is a technology has the potential for exquisite dose painting and structuring in such a manner that it can permit exclusion of normal tissues and sensitive structures from the high dose radiation volume without compromising primary tumor or nodal target coverage. In this phase I/II feasibility trial, radical radiotherapy will be delivered using Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) to a dose of 66-70 Gy to involved areas and to at least 50 Gy to un-involved sites, treated prophylactically. It is hypothesized that the pattern of failure and toxicity profiles of patients treated with helical tomotherapy will demonstrate the greater efficacy of helical tomotherapy, as compared with conventional radiotherapy, in the treatment of cancers of the head and neck.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stage II, III or IV non-metastatic histologically confirmed carcinoma of the head and neck region (Oral cavity, pharynx or larynx).
  2. Treatment with radical radiotherapy with or without chemotherapy
  3. Patients in whom definitive radiotherapy with or without planned neck dissection is the selected curative treatment
  4. ECOG performance status of 0, 1 or 2

Exclusion Criteria:

  1. Previous radiotherapy to head and neck mucosa
  2. Patients with disabling co-morbid conditions, which do not permit effective immobilization
  3. Patients with severe trismus, which disallow effective assessment
  4. Patients in whom it is deemed necessary to commence enteric nutrition prior to the start of treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426504

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Nancy Page     613-737-7700 ext 70301     npage@ohri.ca    
Principal Investigator: Samy El-Sayed, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Study Chair: Samy El-Sayed, MD OHRI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426504     History of Changes
Other Study ID Numbers: 2005781-01H, OTT 05-06
Study First Received: January 23, 2007
Last Updated: July 25, 2007
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Head,
Neck,
Cancer,
Tomotherapy,
IMRT,

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 19, 2013