At a glance
ClinicalIndex Comparison Record- ✓Pathologically proven HNSCC of oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx
- ✓Gross total surgical resection within 63 days prior to registration
- ✓At least one high-risk pathologic feature: extracapsular nodal extension or invasive cancer at primary tumor resection margin
- ✓Pathologic stage III or IV HNSCC with no distant metastases
- ✕Prior invasive malignancy within 3 years, except non-melanomatous skin cancer and select exceptions
- ✕Simultaneous primaries or bilateral tumors, except bilateral tonsil cancers or T1-2, N0, M0 resected differentiated thyroid carcinoma
- ✕Prior systemic chemotherapy or anti-EGF therapy for the study cancer
- ✕Prior radiotherapy to study cancer region with overlapping fields
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Atezolizumab, Biopsy Procedure, and 8 other interventions for Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma and 8 related conditions. Currently recruiting, targeting 613 participants across 342 sites in 3 countries.
Signals
Detailed Summary
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
Study Details
Timeline
Arms & Interventions
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)
Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.
Interventions
Given IV
Undergo biopsy
Undergo collection of blood
Given IV
Given IV
Undergo CT
Given IV
Undergo IMRT
Undergo MRI
Ancillary studies