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

Conditions: Adrenocortical carcinoma
MedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-007262-38-GB

Lead Sponsor: niversity of Birmingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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.