Efficacy of adjuvant mitotane in prolonging recurrence-free survival in patients with adrenocortical carcinoma at low-intermediate risk of recurrence - ADIUVO version 1.0

niversity of Birmingham0 个研究点目标入组 200 人开始时间: 2013年4月30日最近更新: 2013年6月10日

适应症

试验速览

暂无简介。

•1. Histologically confirmed diagnosis of ACC according to Weiss system 2. Low-intermediate risk of relapse defined as: o Stage I-III (according to ENSAT classification 2008) 3. Microscopically complete resection, defined as no evidence of microscopic residual disease based on surgical reports, histopathology and post-operative imaging. Detailed pathological and surgical reports prepared according to guidelines should be available for assessment. 4. Ki 67 /= 18 years 7. ECOG performance status 0-2 8. Adequate bone marrow reserve (neutrophils >/=1000/mm3 and/or platelets >/= 80000/ mm3) 9. Ability to comply with the protocol procedures 10. Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Time between primary surgery and randomisation > 3 months. 2. Repeated surgery for recurrence of disease 3. Persistence of autonomous adrenocortical hormone secretion following surgery. 4. History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years 5. Renal insufficiency (creatinine clearance < 40 ml/min). Creatinine clearence may be calculted according to validated formulas (Crockoft’s or MDRD) 6. Liver insufficiency (serum bilirubin > 2 times the upper normal range and/or serum transaminases (AST/SGOT, ALT/SGPT) >3 times the upper normal range). 7. Pregnancy or breast feeding 8. Previous or current treatment with mitotane or other antineoplastic drugs for ACC 9. Previous radiotherapy of the tumour bed for ACC 10. Any other severe acute or chronic medical or psychiatric condition,or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

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