Post-Operative Concurrent Chemo-Radiotherapy Versus Post-Operative Radiotherapy for Cancer of the Head and Neck
Trans Tasman Radiation Oncology Group (TROG) 05.01 - Post-Operative Concurrent Chemo-Radiotherapy (Carboplatin) Versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck to improve loco-regional relapse
Trans Tasman Radiation Oncology Group (TROG)
350 participants
Apr 20, 2005
Interventional
Conditions
Summary
The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk CSCC of the head and neck, whether there is a difference in time to loco-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on an anticipated accrual of 80 patients/year. A further 2 years follow up is required.
Eligibility
Plain Language Summary
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Interventions
Arm 2: Radiotherapy 60Gy or 66Gy in 30-33 fractions, 5 times a week, over 5-5.5 weeks. Plus, Carboplatin intravenously weekly on either day 1, 2 or 3 of radiation with a max of six doses. Dose of carboplatin is calcualted by a formula that changes the value for each patient. Formula is glomerular filtration rate + 25 x target area under the concentration curve (AUC).
Locations(21)
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ACTRN12607000146493