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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Squamous Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperfractionated Accelerated Radiotherapy

Hypofractionated Accelerated Radiotherapy with integrated neck surgery

Group Type EXPERIMENTAL

hyperfractionated accelerated radiotherapy

Intervention Type PROCEDURE

Interventions

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hyperfractionated accelerated radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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