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Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
Randomized Phase II Component Primary Objective
To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin
Phase III Component Primary Objective
To determine whether the selected experimental arm will improve overall survival (OS) over the control arm of radiation and cisplatin
Randomized Phase II and Phase III Components Secondary Objectives
To improve local-regional disease control;
To compare distant metastasis;
To compare patterns of cancer failure (local, regional, distant) and correlate with radiation dose and technique;
To compare acute toxicity profiles during RT and at completion of treatment;
To compare late toxicity profiles at 1, 3, and 5 years after treatment;
To compare overall quality of life;
To compare patient-reported outcome;
To compare swallowing function at 1 and 2 years;
To investigate associations between acute mucosal toxicity, swallowing function, and QOL;
To compare quality adjusted life years (QALY);
To investigate associations between late toxicity (dysphagia) and QALY;
To determine whether specific molecular profiles are associated with clinical outcomes.
Randomized Phase II Component Primary Objective
To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin
Phase III Component Primary Objective
To determine whether the selected experimental arm will improve overall survival (OS) over the control arm of radiation and cisplatin
Randomized Phase II and Phase III Components Secondary Objectives
To improve local-regional disease control;
To compare distant metastasis;
To compare patterns of cancer failure (local, regional, distant) and correlate with radiation dose and technique;
To compare acute toxicity profiles during RT and at completion of treatment;
To compare late toxicity profiles at 1, 3, and 5 years after treatment;
To compare overall quality of life;
To compare patient-reported outcome;
To compare swallowing function at 1 and 2 years;
To investigate associations between acute mucosal toxicity, swallowing function, and QOL;
To compare quality adjusted life years (QALY);
To investigate associations between late toxicity (dysphagia) and QALY;
To determine whether specific molecular profiles are associated with clinical outcomes.
Recruitment Status
Past Studies