angiosarcoma soft tissue cancer arising from the blood vessels
Conditions
Interventions
3-6 weeks treatment with propranolol according to the treatment plan as stated
in "study design".
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 of 18 years or more; 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 in patients with cutaneous angiosarcoma oAt least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician
Exclusion criteria
Exclusion criteria: o Contraindication for propranolol therapy, o Current treatment with β-blockade therapy. o Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer. o Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer. o Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the clinical response according to RECIST criteria. 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 SD, PR or CR with improvement in clinical characterstics. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the histologic response defined as a decrease of >30% of Ki-67 index between pre- and post-propranolol treatment biopsies. | — |
Countries
Netherlands
Outcome results
None listed