Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Samy El-Sayed, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00426504
First received: January 23, 2007
Last updated: June 4, 2013
Last verified: June 2013
  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: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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 [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
    MEASURING MUCOSITIS


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, [ Time Frame: 1-once 2- 6 monthly ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: November 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiotherapy
Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) with the intend of delivering radical radiotherapy to a dose of 66-70 Gy to involved areas and at least 50 Gy to un-involved sites to be treated prophylactically.
Procedure: Radiotherapy
Helical Tomotherapy Intensity Modulated Radiotherapy (HT-IMRT) with the intend of delivering radical radiotherapy to a dose of 66-70 Gy to involved areas and at least 50 Gy to un-involved sites to be treated prophylactically.
Other Name: Helical tomotherapy IMRT

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426504

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Study Chair: Samy El-Sayed, MD OHRI
  More Information

No publications provided

Responsible Party: Dr. Samy El-Sayed, MD Radiation Oncologist, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00426504     History of Changes
Other Study ID Numbers: 2005781-01H, OTT 05-06
Study First Received: January 23, 2007
Last Updated: June 4, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 22, 2014