| Eligibility |
Inclusion Criteria:
- 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
1. T1 NO
2. T2 NO 3.143 Hypopharynx
1. T1 NO 3.144 Larynx
1. T1 NO
2. 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.
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