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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188318
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 9, 2016
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Procedure: hyperfractionated accelerated radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 1998
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Toxicities as per CTCAE [ Time Frame: 1 yr ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188318

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: John Waldron, MD Princess Margaret Hospital, Canada

Responsible Party: University Health Network, Toronto Identifier: NCT00188318     History of Changes
Other Study ID Numbers: UHN REB 01-0557-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

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