Angiosarcoma is a rare and aggressive form of soft tissue sarcoma. Prior work demonstrates very poor outcomes, with most patients developing metastatic disease and less than 50% surviving greater than 5 years. In other soft tissue sarcomas, the use of radiotherapy and/or chemotherapy have improved progression-free survival in patients undergoing limited, organ-sparing surgeries. Taxane chemotherapy has shown efficacy in patients with metastatic angiosarcoma, but this has not been tested in patients with localized disease. This study examines the efficacy of induction paclitaxel followed by concurrent chemoradiation therapy with paclitaxel prior to curative surgical resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
-Commercial supply
-Patients may be treated with electrons, 3D conformal photon radiotherapy, intensity modulated photon radiotherapy (IMRT), proton radiation therapy, or a combination of these.
-Within 1 week (prior to cycle 1 of paclitaxel preferred but not required), pre-radiation therapy (any time weeks 5-7 as long as radiation therapy has not started), post-radiation therapy (day of last fraction), 14 days post-radiation therapy, and within 2 weeks post-surgery
Washington University School of Medicine
St Louis, Missouri, United States
Progression-free survival (PFS) rate
* PFS is defined as the duration of time from pathologic diagnosis to time of progression or death, whichever occurs first. * Progression is defined as the appearance of new angiosarcoma lesions as determined by clinical exam, radiography, and/or pathologic confirmation.
Time frame: At year 2 follow-up (estimated to be 2 years and 12 weeks)
Overall survival (OS) rate
-Patients that have died from any cause will be censored from the OS rate calculation
Time frame: At year 2 follow-up (estimated to be 2 years and 12 weeks)
Pathologic complete response rate (pCR)
-Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist
Time frame: At the time of surgery (approximately 19 weeks)
Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0
Time frame: From start of radiation through 90 days after start of radiation
Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0
Time frame: From 91 days through year 2 follow-up
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