Enrollment complete
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
NCT No.: NCT01302834
Study Type: Clinical Trial
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Purpose
This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
Detailed Description
OBJECTIVES:
Primary:
To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.
Secondary
To monitor and compare progression-free survival for "safety".
To compare patterns of failure (locoregional vs distant).
To compare acute toxicity profiles (and overall toxicity burden).
To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2 years).
To compare QOL Swallowing Domains short-term and long-term.
To compare clinician-reported versus patient-reported CTCAE toxicity events.
To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
To explore differences in work status and time to return to work.
To compare patient-reported changes in hearing.
To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.
To pilot CASI collection of patient reported outcomes in a cooperative group setting.
To determine whether specific molecular profiles are associated with overall or progression-free survival.
To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.
OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (= 10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms.
Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.
After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
- Zubrod performance status 0-1
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Platelet count >= 100,000/mm³
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Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)
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AST or ALT <= 3 times upper limit of normal
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Serum creatinine <= 1.5 mg/dL OR creatinine clearance >= 50 mL/min
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Exclusion Criteria
- Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer allowed)
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Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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Prior cetuximab or other anti-EGFR therapy
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Prior allergic reaction to cisplatin or cetuximab
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Prior invasive malignancy except non-melanoma skin cancer, or malignancy for which the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix)
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Keywords and/or Specific Medical Conditions
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human papilloma virus infection
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Otorhinolaryngologic Diseases
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Otorhinolaryngologic Neoplasms
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Physiological Effects of Drugs
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Radiation-Sensitizing Agents
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stage III squamous cell carcinoma of the oropharynx
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stage IV squamous cell carcinoma of the oropharynx
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Sponsors
- National Cancer Institute (NCI)
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- Radiation Therapy Oncology Group
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