Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)

February 8, 2016 updated by: University Health Network, Toronto

A Phase II Study of Hyperfractionated Accelerated Radiotherapy Delivered With Integrated Neck Surgery for Node-positive Cases in Squamous Cell Carcinoma of the Head and Neck

This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Histologically proven squamous cell carcinoma
  • Larynx & pharynx (except Nasopharyngeal carcinoma)
  • Stage III & IV, but any stage hypopharynx
  • Informed Consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperfractionated Accelerated Radiotherapy
Hypofractionated Accelerated Radiotherapy with integrated neck surgery
Procedure: hyperfractionated accelerated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicities as per CTCAE
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: John Waldron, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 01-0557-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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