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

Phase 2

Completed

• Conditions: Carcinoma, Squamous Cell
• Interventions: Procedure: hyperfractionated accelerated radiotherapy

• Registration Number: NCT00188318
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperfractionated Accelerated Radiotherapy	hyperfractionated accelerated radiotherapy	Hypofractionated Accelerated Radiotherapy with integrated neck surgery

Primary Outcome Measures

Name	Time	Method
Toxicities as per CTCAE	1 yr

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada