First International Randomized trial in locally advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Collaborative group for Adrenocortical Carcinoma Therapy (COAT)0 个研究点目标入组 300 人开始时间: 2006年7月21日最近更新: 2015年7月10日

试验速览

暂无简介。

•Histologically confirmed diagnosis of adrenocortical carcinoma
•Locally advanced or metastatic disease not amenable to radical surgery resection (Stage III-IV)
•Radiologically monitorable disease
•ECOG performance status 0-2
•Life expectancy > 3 months
•Age =18 years
•Adequate bone marrow reserve (neutrophils =1500/mm3 and platelets =100.000/mm3)
•Effective contraception in pre-menopausal female and male patients
•Patient’s written informed consent
•Ability to comply with the protocol procedures (including availability for follow-up visits)
•Previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiably afterwards.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of prior malignancy, except for cured non-melanoma skin cancer, curatively in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years.
•Previous cytotoxic chemotherapy for adrenocortical carcinoma
•Renal insufficiency (serum creatinine =2 mg/dl or creatinine clearance = 50 ml/min)
•Hepatic insufficiency (serum bilirubin =2 x the institutional upper limit of normal range and/or serum transaminases = 3 x the institutional upper limit of normal range; exception: in patients on mitotane transaminase levels up to 5 x the institutional upper limit of normal range are acceptable)
•Pregnancy or breast feeding
•Known hypersensitivity to any drug included in the treatment protocol
•Presence of active infection
•Any other severe clinical condition that in the judgment of the local investigator would lace the patient at undue risk or interfere with the study completion
•Decompensated heart failure (ejection fraction <50%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, and uncontrolled cardiac arrhythmia
•Current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma Prisoners

发起方

Collaborative group for Adrenocortical Carcinoma Therapy (COAT)