COSA Head and Neck Study

Phase 3

Completed

• Conditions: Histologically confirmed SCC of oral cavity, pharynx, hypopharynx and larynx.; Cancer - Head and neck; Surgery - Other surgery

• Registration Number: ACTRN12605000768695
• Lead Sponsor: Investigator Initiated. Study Chairman: Dr David Dalley from St Vincents Hospital NSW. Co-ordinating Centre: Clinical Trials Centre, University of Sydney.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Histologically confirmed SCC of oral cavity, pharynx, hypopharynx and larynx.Patients planned to receive surgery which would result in significant deformity or disfiguration or significant loss of function. Significant will be left to the discretion of the investigators.No prior chemotherapy, radiotherapy or surgery ( other than biopsy).Documentation of measurable disease(see section).ECOG performance status of 2 or better.Geographically assessable for treatment follow up.Adequate bone marrow reserves with WBC >3.9 and platelets > 100.Adequate renal and hepatic function with creatinine < 0.13mmol/L or creatinine clearance >0.8ml/sec and liver function test < 1.5 x the upper limit of normal.Be able to complete quality of life assessment.Have given informed consent.

Exclusion Criteria

Past or current malignancies at other sites except adequately treated squamous or basal cell carcinoma of the skin or in-situ carcinoma of the cervix.Metastatic tumour (outside local area and its draining/regional nodes).No upper age limit is specified; entry will be at the discretion of the investigator.Tumours originating in the skin are not eligible.

Study & Design

• Study Type: Interventional
• Study Design: Not specified