Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT03370367
Eligibility Criteria:
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
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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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03370367
Study Brief:
Protocol Section:
NCT03370367