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Clinical Trial ECOGTHNR1016

Title

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Principal Investigator(s)

Kenneth Niermann

Details

  • Protocol No. ECOGTHNR1016
  • Open Date: 09/25/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival
  • Disease Sites: Head/Neck
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: Cetuximab; Cetuximab (Erbitux); Cisplatin
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01302834
  • Secondary Protocol No: RTOG 1016

Description

Participants are being asked to take part in this study because they have head and neck cancer that may be positive for the HumanPapillomavirus (HPV).The purpose of this study is to compare the effects, good and/or bad, of two standard treatments for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. The two treatments may be comparable in treating cancer, but radiation and cetuximab may result in less severe side effects. Cisplatin is a classic chemotherapy drug. Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions. Radiation and cetuximab may result in less severe side effects. However, it is unknown whether it is equally effective as radiation and cisplatin for this type of cancer. This study is being done in patients whose head and neck cancer was caused by Human Papillomavirus (HPV). Some studies have found that patients with HPV positive oropharynx cancer have a better response to treatment and live longer. Thus, this study aims to see if treatment with radiation plus cetuximab has less side effects and is as effective as radiation plus cisplatin.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

DISEASE CHARACTERISTICS:
• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
• No cancer from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal, or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive
• No carcinoma of the neck of unknown primary site origin (even if p16 positive)
• Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx
• Clinical evidence should be documented; may consist of palpation, imaging, or endoscopic evaluation; and should be sufficient to estimate the size of the primary (for T stage)
• No distant metastasis or adenopathy below the clavicles
• Patients must be positive for p16, determined by the OSU Innovation Center CLIA lab prior to step 2 registration (randomization)
• Paraffin-embedded cytology specimens are acceptable for p16 evaluation, but cytology smears are not
• Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
• Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site
• Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions
• Fine-needle aspirations of the neck are insufficient due to limited tissue for retrospective central review
• Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required
• Clinical stage T1-2 N2a-N3 or T3-4 any N, including no distant metastases
• No clinical stage T1-2 N0-1
• No simultaneous primaries or bilateral tumors
PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
• Bilirubin ≤ 2 mg/dL
• AST or ALT ≤ 3 times upper limit of normal
• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
• Negative pregnancy test
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study, and until at least 60 days following the last study treatment
• Patients who are HIV-positive and have no prior AIDS-defining illness and have CD4 cells of at least 340/mm³ are eligible
• HIV status must be known prior to registration
• No multidrug resistance for HIV infection
• Not seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or hepatitis C (anti-hepatitis C antibody positive)
• Immunity to hepatitis B (anti-hepatitis B surface antibody positive) allowed
• No 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)
• No severe, active co-morbidity, defined as any of the following:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Transmural myocardial infarction within the last 6 months
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
• Immunocompromised patients
• No prior allergic reaction to cisplatin or cetuximab
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior systemic chemotherapy for the study cancer
• Prior chemotherapy for a different cancer allowed
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• No prior cetuximab or other anti-EGFR therapy
• No concurrent amifostine as a radioprotector
• No concurrent granulocyte colony-stimulating factor or erythropoietin