NCT03370367已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 主要终点
- The time to diagnosis of second primary for the treatment versus control groups.
研究概览
简要总结
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 probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include:
- The time to diagnosis of second primary for the treatment versus control groups.
- Survival time for the treatment versus control groups.
- Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •T2 NO 3.142 Oropharynx
- •T2 NO 3.143 Hypopharynx
- •T1 NO 3.144 Larynx
- •Age greater than 18 years.
- •ECOG performance status 0 or
- •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
排除标准
- •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.
研究组 & 干预措施
Arm B
Placebo Comparator
Take 2 placebo pills once a day for up to 2 years.
干预措施: Placebo (Other)
Arm A
Experimental
13-cis retinoic acid will be dispensed in 3.75 mg and 5 mg gelatin capsules. Take 2 capsules once a day for up to 2 years.
干预措施: 13-cis retinoic acid (Drug)
结局指标
主要结局
The time to diagnosis of second primary for the treatment versus control groups.
时间窗: 20 years
次要结局
- Survival time for the treatment versus control groups.(20 years)
研究者
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