This phase II trial studies how well paclitaxel and radiation therapy work in treating patients with cutaneous (skin) angiosarcoma. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Cutaneous angiosarcoma is usually treated with paclitaxel followed by surgery. Treating cutaneous angiosarcoma more aggressively by adding radiation therapy to paclitaxel may improve initial response to treatment and delay or prevent the cancer from coming back after surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT03921008.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Anthony J. Apicelli
Phone: 314-362-8610
PRIMARY OBJECTIVE:
I. To assess progression-free survival (PFS) at 2 years for patients with cutaneous angiosarcoma treated with induction paclitaxel followed by concurrent paclitaxel and radiation therapy.
SECONDARY OBJECTIVES:
I. To assess overall survival for patients with cutaneous angiosarcoma treated with induction paclitaxel followed by concurrent paclitaxel and radiation therapy.
II. To assess the pathological complete response rate for patients with cutaneous angiosarcoma undergoing surgery after treatment with induction paclitaxel followed by concurrent paclitaxel and radiation therapy.
III. To assess the rate of grade 3 and higher acute treatment-related toxicity of concurrent paclitaxel and radiation therapy.
IV. To assess the rate of grade 3 and higher late treatment-related toxicity of concurrent paclitaxel and radiation therapy.
OUTLINE:
Patients receive paclitaxel intravenously (IV) over 1 hour weekly for 12-16 weeks in the absence of disease progression of unacceptable toxicity. Between 5-7 weeks of paclitaxel treatment, patients also undergo radiation therapy over 15-30 minutes daily (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 6 weeks after completion of paclitaxel and radiation therapy, followed by an additional 5-9 days of radiation therapy at the discretion of the treating physician. Patients who do not undergo surgery may also undergo radiation therapy for 9 additional days after completion of paclitaxel and radiation therapy at the discretion of the treating physician. Patients undergo computed tomography (CT) scan and/or positron emission tomography (PET) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 6 weeks of end of radiation and every 3 months for 2 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorAnthony J. Apicelli
