Status:
COMPLETED
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
Lead Sponsor:
Eastern Cooperative Oncology Group
Conditions:
Stage I-II Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high pr...
Eligibility Criteria
Inclusion
- 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
- T1 NO
- T2 NO 3.142 Oropharynx
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- T1 NO
- T2 NO 3.143 Hypopharynx
- 1\. T1 NO 3.144 Larynx
- T1 NO
- 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
- 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.
Key Trial Info
Start Date :
May 15 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2015
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT03370367
Start Date
May 15 1989
End Date
April 14 2015
Last Update
June 15 2023
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