Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to
help focus thin beams of radiation directly on the tumor, and giving radiation therapy in
higher doses over a shorter period of time, may kill more tumor cells and have fewer side
effects. 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 carry tumor-killing substances to them. It is not yet known whether radiation
therapy is more effective when given alone or together with cetuximab in treating patients
with head and neck cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
works compared with radiation therapy given together with cetuximab in treating patients who
have undergone surgery for locally advanced head and neck cancer.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Head and Neck Cancer
Enrollment Eligibility
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superseded by intraoperative negative margins (similarly, patients whose tumors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 < 3.0 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