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Clinical Trial ECOGTHNR0920

Title

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Principal Investigator(s)

Anthony Cmelak

Details

  • Protocol No. ECOGTHNR0920
  • Open Date: 09/12/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: International
  • Objective: Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery
  • Disease Sites: Head/Neck
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics; Radiotherapy
  • Drugs: Cetuximab; Cetuximab (Erbitux)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01311063
  • Secondary Protocol No: RTOG 0920

Description

Participants are being asked to take part in this research study because they have head and neck cancer that after surgery has an intermediate risk of recurring. The standard treatment of surgery (which they have had) followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the FDA in 2006 for the treatment of head and neck cancer. The purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone with radiation therapy and cetuximab on participants and their cancer to find out which is better. In this study, they will get either radiation therapy alone OR radiation therapy and cetuximab. If they participate in this study, participants will receive intensity modulated radiation therapy (IMRT). IMRT is a form of radiation in which radiation beams are designed to avoid important normal parts of their body, such as the salivary glands. Study doctors also may decide to use a technique called image guided radiation therapy (IGRT). The purpose of IGRT is to give radiation treatment more accurately to tumors while decreasing the radiation to normal tissues. Small adjustments in the radiation treatment are made each treatment day based on x-ray images taken right before each day's treatment to ensure that radiation treatments are given as accurately as possible. Use of IGRT may lead to improved accuracy of radiation treatment compared to regular radiation therapy and eventually, that will be more useful against cancer. At this time, however, there is no proof that using this technique is more useful against cancer than regular radiation treatment without this technique. This study is being conducted by the Radiation Therapy Oncology Group (RTOG). RTOG is a group of researchers at different sites that conduct research for the National Cancer Institute (NCI). Study doctors are members of RTOG or another group participating in the study. About 700 people will take part in this study across all sites. About 8 people will take part at Vanderbilt.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:
• Histologically confirmed squamous cell carcinoma (including variants, such as verrucous carcinoma, spindle cell carcinoma, or carcinoma not otherwise specified) of the head and neck, including the following subtypes:
• Oral cavity
• Oropharynx
• Larynx
• Clinical stage T1, N1-2, M0 OR T2-4a, N0-2, M0 disease based on the following diagnostic workup within the past 8 weeks:
• General history and physical examination by a Radiation Oncologist and/or Medical Oncologist
• Chest x-ray or chest CT scan (with or without contrast) or chest CT/PET scan (with or without contrast)
• Must have undergone gross total resection of the primary tumor with curative intent within the past 7 weeks with surgical pathology demonstrating ≥ 1 of the following criteria for "intermediate" risk of recurrence:
• Perineural invasion
• Lymphovascular invasion
• Single lymph node > 3 cm or ≥ 2 lymph nodes (all < 6 cm) (no extracapsular extension)
• Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin, and/or an initially focally positive margin that is subsequently superseded by intraoperative negative margins (similarly, patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible)
• Pathologically confirmed T3 or T4a primary tumor
• T2 oral cavity cancer with > 5 mm depth of invasion
• No positive margin(s) (defined as tumor present at the cut or inked edge of the tumor), nodal extracapsular extension, and/or gross residual disease after surgery
PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
• Total bilirubin < 2 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN
• Serum creatinine < 2 times ULN OR creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancy within the past 3 years, except for nonmelanomatous skin cancer or previously treated carcinoma in situ of the breast, oral cavity, or cervix
• No simultaneous primary or bilateral tumors
• No severe, active co-morbidity, including any of the following:
• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• Transmural myocardial infarction within the past 6 months
• Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
• Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to have required oxygen therapy within the past year
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• AIDS based on current Centers for Disease Control (CDC) definition
• Grade 3-4 electrolyte abnormalities according to CTCAE, v. 4, including any of the following:
• Serum calcium (ionized or adjusted for albumin) < 7 mg/dL or > 12.5 mg/dL*
• Glucose < 40 mg/dL or > 250 mg/dL
• Magnesium < 0.9 mg/dL or > 3 mg/dL*
• Potassium < 3.5 mmol/L or > 6 mmol/L*
• Sodium < 130 mmol/L or > 155 mmol/L* NOTE: *Despite intervention to normalize levels.
• No prior allergic reaction to cetuximab
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for this cancer
• Prior chemotherapy or anti-EGF therapy for a different cancer allowed
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• No concurrent amifostine as a radioprotector
• No concurrent granulocyte colony-stimulating factor or erythropoietin