CompletedPhase 3ACTRN12605000768695

COSA Head and Neck Study

A Randomised Comparative Study of Surgery Versus Radiotherapy and Chemotherapy in Patients With Squamous Cell Carcinoma of the Head & Neck

Sponsor

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

Enrollment

270 participants

Start Date

May 1, 1986

Study Type

Interventional

Conditions

Histologically confirmed SCC of oral cavity, pharynx, hypopharynx and larynx.

Eligibility

Sex: Both males and females

Inclusion Criteria1

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 Criteria1

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.

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Interventions

Surgery, chemotherapy, radiation therapy. Patients randomised to surgery will proceed to their planned surgery within three weeks of radiotherapy. Post operative radiotherapy may be given if indicate

Surgery, chemotherapy, radiation therapy. Patients randomised to surgery will proceed to their planned surgery within three weeks of radiotherapy. Post operative radiotherapy may be given if indicated. Patients randomised to chemotherapy will be given chemotherapy by intravenous infusion for 4 days, repeated at 21 day intervals. Radiotherapy will commence following the 3rd course of chemotherapy. If required surgery will be conducted at this time. Chemotherapy will then be given simultaneously with the radiotherapy and an additional chemotherapy will be given after the radiotherapy.

Locations(1)

Australia

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ACTRN12605000768695