Phase III double-blind randomized trial of 13-cis retinoic acid (13-CRA) to prevent second primary tumors (SPTs) in Stage I non-small cell lung cancer

Originating Group

MDACC ID91-025

P.I.: Dr. J. Roth

Participating Groups

Objectives

1. To evaluate the efficacy of 13-cis-retinoic acid (13-cRA) in reducing the incidence of SPTs in patients who have been treated for Stage I non-small cell lung cancer with complete surgical resection.
2. To evaluate the qualitative and quantitative toxicity of low-dose 13-cRA in a daily administration schedule.
3. To compare the overall survival of patients treated with 13-cRA vs. patients treated with placebo.

Eligibility

1. Patients who had histologic proof of complete resection of a non-small cell lung cancer (e.g. squamous, adenocarcinoma, large cell carcinoma, etc.) which was staged postoperatively as Stage I (T1N0M0, T2N0M0), who are currently free of disease.
2. Patients may not have received and may not currently be receiving chemotherapy, radiotherapy, or immunotherapy for lung cancer.
3. Eligible patients are those between 6 weeks and up to 36 months from date fo surgical resection.
4. Pathology material from the initial diagnosis must be available for review if recurrence occurs.
5. Age > 18 yrs, females not of childbearing potential and signed informed consent.
6. Bilirubin < 1.5mg%, SGPT < 56 IU/ml., or SGOT < 40 IU/ml. , WBC >3,000 cu/mm, platelet > 100,000 cu/mm, creatinine < 1.5 mg%, fasting triglycerides < 320 mg/dL.
7. Life expectancy > 12 months and Zubrod performance status 0-2.
8. Ineligiblity criteria: a) use of megadose vitamin A (> 25,000 IU/day), or > 30mg/day of beta-carotene within 3 months of study entry or during study, b) concurrent cancers or any prior cancer history within 5 years except localized non-melanoma skin cancer, c) history of greater than one lung cancer primary at anytime, d) synchronous lesions, even though resectable.

Schema

Comments

trial completed

accrual goal of 1232 patients reached in 2/97