Cancer Type: Head & Neck
Study Type: Treatment
Phase: Phase II/III
Principal Investigator: Caudell, Jimmy
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.
Chemotherapy (NOS); Immunotherapy; Radiotherapy
Atezolizumab (Tecentriq); Cetuximab (); Erbitux (Cetuximab); Taxotere (docetaxel); cisplatin (); docetaxel ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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