Radiation Therapy Using Helical Tomotherapy IMRT for Head and Neck Cancer

NCT00426504 | Completed

• 2 other identifiers: 2005781-01HOTT 05-06
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Head,; Neck,; Cancer,; Tomotherapy,; IMRT,

Outcome Measures

Primary Outcomes (1)

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

  MEASURING MUCOSITIS

  weekly

Secondary Outcomes (1)

• 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,

  1-once 2- 6 monthly

Study Arms (1)

radiotherapy

EXPERIMENTAL

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

Interventions

Radiotherapy PROCEDURE

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.

Also known as: Helical tomotherapy IMRT

radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous radiotherapy to head and neck mucosa
• Patients with disabling co-morbid conditions, which do not permit effective immobilization
• Patients with severe trismus, which disallow effective assessment
• Patients in whom it is deemed necessary to commence enteric nutrition prior to the start of treatment.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Samy El-Sayed, MD

  OHRI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 30, 2020

Record last verified: 2020-03

Locations

CA (1)