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Site for 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 (PSCI# 20-106) (RTOG-1216)

To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC.

To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT01810913
SITE00000898
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 Negative), larynx, or hypopharynx within 63 days prior to registration
Pathologic stage III or IV HNSCC, including no distant metastases
Zubrod Performance Status of 0-1 within 14 days prior to registration
Adequate hepatic function
Exclusion Criteria:
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note that prior chemo for a different cancer is allowable
Severe, active co-morbidity
Grade 3-4 electrolyte abnormalities
Prior allergic reaction to cetuximab
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Location Contacts
Hershey, PA ,