NL-OMON36658已完成3 期
Efficacy of adjuvant mitotane treatment in prolonging recurrence -free survival in -patients with adrenocortical carcinoma at low-intermediate risk of recurrence - ADIUVO
Azienda Ospedaliera S. Luigi Gonzaga0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed diagnosis of ACC.
- •Low-intermediate risk of relapse defined as: stage I-III ACC(according to the ENS@T classification 2008).
- •Microscopically complete resection, defined as no evidence of microscopic residual disease based on surgical reports, histopathology and post-operative imaging.
- •Ki67 index < or equal 10 %.
- •Post-operative imaging demonstrating no evidence of disease within 4 weeks before randomization.
- •ECOG performance status 0-2.
- •Age equal to or older then 18 years
- •Adequate bone marrow reserve (neutrophils equal or higher then 1.0 * 10^9/L and/or platelets equal or higher then 80.0 * 10^9/L)
- •Ability to comply with the protocol procedures
- •Written informed consent
排除标准
- •Time between primary surgery and randomization > 3 months.
- •Repeated surgery for recurrence of disease.
- •Renal insufficiency (creatinine clearance <40 ml/min) or liver insufficiency (serum bilirubin >2 times the upper normal range and/ or serum transamininase (AST,ALT)> 3 times the upper normal range).
- •History of recent or active prior malignancy, except for cured non melanoma skin cancer, cured insitu cervical carinoma, or other treated malignancies where there has been no evidence of disease for at least tree years.
- •Previous or current treatment with mitotane or other antineoplastic drugs for ACC.
- •Previous radiotherapy for ACC.
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