Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

• Informed consent i obtained, the approved form is signed, and on file at the institution.
• Histologically confirmed squamous cell carcinoma.
• All chest x-rays and cervical spine x-rays done after definitive treatment within 35 days prior to randomization and all hematology andchemistries done within 2 weeks prior to randomization.

• The following sites and stages of cancers will be eligible. Oral Cavity

  1. T1 NO
  2. T2 NO 3.142 Oropharynx

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  1. T1 NO
  2. T2 NO 3.143 Hypopharynx
  1. T1 NO 3.144 Larynx
  2. T1 NO
  3. T2 NO
• Age greater than 18 years.
• ECOG performance status 0 or 1.
• Patients must have adequate bone marrow, hepatic and renal function defined as follows: WBC >3,500/mm, Platelets > 125,000/mm.3 Total Bilirubin \< 2 mg%, Serum creatinine \< 2.5 mg%. Serum SGOT \< 2x normal, Alkaline Phosphatase \< 2x normal. Fasting Serum triglyceride levels \< 210 mg %. Fasting cholesterol \< 350 mg %. Patient may not be under systemic therapy for hyperlipidemia or have symptomatic arteriosclerotic coronary artery disease or have undergone coronary bypass surgery.
• The patient must have completed primary treatment of their cancer with surgery and/or radiation therapy within 730 days prior to randomization.
• The patient has had surgery and/or radiation therapy as outlined in Sections 5.0 and 6.0, and has been rendered disease-free.
• If currently receiving, patient must discontinue mega vitamin doses

Exclusion Criteria:

• Women of child bearing potential.
• Patient with severe coronary artery disease (Class III-IV New York Heart Association.)
• Histology other than squamous cell carcinoma.
• Distant metastases.
• Completion of previous treatment for their primary cancer with radiation, or surgery (except for biopsy) more than 730 days ago.
• Prior, synchronous, or concurrent malignancy except basal cell skin cancer.
• Failure to be rendered disease-free of primary tumor (includes positive surgical margins).
• The patient has had prior therapy other than that outlined in Sections 5.0 and 6.0 of the protocol.