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
Phase II Component Primary Objective (20-MAR-2020) To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin *Phase II Component is complete and the docetaxel-cetuximab arm has advanced to Phase III; please continue to Phase III Component.
Phase III Component Primary Objectives (20-MAR-2020)
To determine if the combination of docetaxel-cetuximab and IMRT is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC.
To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC.
Phase III Component Secondary Objectives (05-JUN-2020) Note: All of the secondary objectives will be tested independently in the RT-docetaxel-cetuximab vs. RT-cisplatin arms and in the RT-atezolizumab-cisplatin vs. RT-cisplatin arms.
To compare disease-free survival (DFS) between each experimental arm and the control arm;
To determine whether each experimental arm improves local-regional disease control and the rate of distant metastasis;
To compare acute toxicity profiles between each experimental arm and the control arm;
To compare late toxicity profiles at 1, 3, and 5 years after treatment;
To assess long term DFS and OS between each experimental arm and the control arm.
To compare symptom burden, as measured by the MDASI-HN (primary PRO), and quality of life, as measured by the FACT-H&N (secondary PRO), between each experimental arm and the control arm.