Trial Search Results

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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 carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology


  • Biological: cetuximab
  • Drug: cisplatin


Phase 3



   - 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

      - 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


   - 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

      - 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

      - 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


   - 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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting