eoadjuvant propranolol in angiosarcoma patients
- Conditions
- Angiosarcoma
- Registration Number
- NL-OMON23603
- Lead Sponsor
- The Netherlands Cancer Institute Antoni van Leeuwenhoek ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the clinical response according to RECIST 1.1 criteria. <br>If propranolol leads to a response in =3 out of 14 patients, this treatment modality is highly interesting and should be tested further in a randomized trial. If propranolol leads to a response in =3 out of 14 patients, this treatment modality is highly interesting and should be tested further in a randomized trial. A response is defined as CR, PR, or SD with an improvement in clinical characteristics, like thickness, erythema, necrosis or edema of the inflicted area.
- Secondary Outcome Measures
Name Time Method The secondary endpoint is the histologic response defined as a decrease of >30% of Ki-67 index between pre- and post-propranolol treatment biopsies.