eoadjuvant trial on the efficacy of propranolol monotherapy in angiosarcoma.

The Netherlands Cancer Institute Antoni van Leeuwenhoek ziekenhuis0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•oHistological proof of angiosarcoma
•oPatients with primary, recurrent and metastasised disease are eligible;
•oPatients with a window of at least 3 weeks before surgery or systemic therapy;
•oAge =18 years;
•oAble and willing to give written informed consent;
•oWHO performance status of 0, 1 or 2;
•oEvaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated
•oMinimal acceptable safety laboratory values
•oANC of = 1.5 x 109 /L
•oPlatelet count of = 100 x 109 /L
•oHepatic function as defined by serum bilirubin = 1.5 x ULN, ASAT and ALAT = 2.5 x ULN
•oRenal function as defined by serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min (by Cockcroft-Gault formula);
•oAt least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

•oContraindication for propranolol therapy, like severe hypotension or bradycardia, sick-sinus syndrome, second or third grade heart block, cardiogenic shock, untreated heart failure, severe peripheral vascular disease asthma or other obstructive lung diseases, untreated pheochromocytoma, metabolic acidosis, prolonged fasting.
•oCurrent treatment with ß-blockade therapy.
•oAny anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
•oConcurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
•oPatients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
•oEvidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;
•oPregnancy;
•oLegal incapacity.

发起方

The Netherlands Cancer Institute Antoni van Leeuwenhoek ziekenhuis