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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) (COMPLETE AS OF 20-MAR-2020) II. To determine if the combination of docetaxel-cetuximab and intensity-modulated radiation therapy (IMRT) is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). (Phase III) III. 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)

SECONDARY OBJECTIVES:

I. To compare disease-free survival (DFS) between each experimental arm and the control arm. (Phase III) II. To determine whether each experimental arm improves local-regional disease control and the rate of distant metastasis. (Phase III) III. To compare acute toxicity profiles between each experimental arm and the control arm. (Phase III) IV. To compare late toxicity profiles at 1, 3, and 5 years after treatment. (Phase III) V. To assess long term DFS and OS between each experimental arm and the control arm. (Phase III)

EXPLORATORY OBJECTIVE:

I. To collect blood and tissue specimens for future translational research. (Phase III)

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM 1: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks and receive concurrent cisplatin intravenously (IV) over 1-2 hours once weekly for 6 weeks.

ARM 2: Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. (CLOSED AS OF 20-MAR-2020)

ARM 3: 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 concurrent receive docetaxel once weekly for 6 weeks.

ARM 4: 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.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma
  • Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
  • Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7

NCT number NCT04411121
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Suspended
Phase Phase 2/Phase 3
Start date March 18, 2013

See also
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Completed NCT01935921 - Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer Phase 1