Back to resultsHardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)
Primary Purpose
Carcinoma, Squamous Cell
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
hyperfractionated accelerated radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell
Eligibility Criteria
Inclusion Criteria: Histologically proven squamous cell carcinoma Larynx & pharynx (except Nasopharyngeal carcinoma) Stage III & IV, but any stage hypopharynx Informed Consent Exclusion Criteria: -
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperfractionated Accelerated Radiotherapy
Arm Description
Hypofractionated Accelerated Radiotherapy with integrated neck surgery
Outcomes
Primary Outcome Measures
Toxicities as per CTCAE
Secondary Outcome Measures
Full Information
NCT ID
NCT00188318
First Posted
September 9, 2005
Last Updated
February 8, 2016
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188318
Brief Title
Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperfractionated Accelerated Radiotherapy
Arm Type
Experimental
Arm Description
Hypofractionated Accelerated Radiotherapy with integrated neck surgery
Intervention Type
Procedure
Intervention Name(s)
hyperfractionated accelerated radiotherapy
Primary Outcome Measure Information:
Title
Toxicities as per CTCAE
Time Frame
1 yr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven squamous cell carcinoma
Larynx & pharynx (except Nasopharyngeal carcinoma)
Stage III & IV, but any stage hypopharynx
Informed Consent
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Waldron, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)
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