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Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
First part of the study: The purpose of this part of the study is to find out what effects, good and/or bad, one of the following treatments has on you and your cancer. In this part of the study, you will receive one of the following treatments: - Standard treatment: radiation therapy and the drug cisplatin - Experimental treatment: radiation therapy and the drug docetaxel - Experimental treatment: radiation therapy and the drugs docetaxel and cetuximab Second part of the study: The purpose of this part of this study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) with one of the experimental treatments chosen from the first part of the study (either radiation therapy + docetaxel or radiation therapy + cetuximab + docetaxel) to find out which is better. In this part of the study, participants will get either the standard treatment or the experimental treatment.
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 1 To improve local-regional disease control; 2 To compare distant metastasis; 3 To compare patterns of cancer failure (local, regional, distant) and correlate with radiation dose and technique; 4 To compare acute toxicity profiles during RT and at completion of treatment; 5 To compare late toxicity profiles at 1, 3, and 5 years after treatment; 6 To compare overall quality of life; 7 To compare patient-reported outcome; 8 To compare swallowing function at 1 and 2 years; 9 To investigate associations between acute mucosal toxicity, swallowing function, and QOL; 10 To compare quality adjusted life years (QALY); 11 To investigate associations between late toxicity (dysphagia) and QALY; 12 To determine whether specific molecular profiles are associated with clinical outcomes.
Atezolizumab (Tecentriq); Cetuximab (); Erbitux (Cetuximab); Taxotere (docetaxel); cisplatin (); docetaxel ()
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