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Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

Status
Temporarily Closed
Cancer Type
Oral Cancer
Trial Phase
Phase II
Phase III
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01810913
Protocol IDs
RTOG 1216 (primary)
NCI-2013-00500
U10CA021661
Study Sponsor
Radiation Therapy Oncology Group

Summary

This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

Objectives

PRIMARY OBJECTIVES:

I. To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) II. To determine whether the selected experimental arm will improve overall survival (OS) over the control arm of radiation and cisplatin. (Phase III)

SECONDARY OBJECTIVES:

I. To improve local-regional disease control. II. To compare distant metastasis. III. To compare patterns of cancer failure (local, regional, distant) and correlate with radiation dose and technique.

IV. To compare acute toxicity profiles during radiation therapy (RT) and at completion of treatment.

V. To compare late toxicity profiles at 1, 3, and 5 years after treatment. VI. To compare overall quality of life. VII. To compare patient-reported outcome. VIII. To compare swallowing function at 1 and 2 years. IX. To investigate associations between acute mucosal toxicity, swallowing function, and quality of life (QOL).

X. To compare quality adjusted life years (QALY). XI. To investigate associations between late toxicity (dysphagia) and QALY. XII. To determine whether specific molecular profiles are associated with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 3 treatment groups.

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

ARM 2: Patients undergo IMRT as in Arm I and receive docetaxel IV once weekly for 6 weeks.

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 receive docetaxel once weekly for 6 weeks.

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.

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