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

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Squamous Cell

Treatments: Procedure: hyperfractionated accelerated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00188318

UHN REB 01-0557-C

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 1 patient group

Hyperfractionated Accelerated Radiotherapy

Experimental group

Description:

Hypofractionated Accelerated Radiotherapy with integrated neck surgery

Treatment:

Procedure: hyperfractionated accelerated radiotherapy