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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel and Radiation | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | -Commercial supply |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate |
| At year 2 follow-up (estimated to be 2 years and 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) rate | -Patients that have died from any cause will be censored from the OS rate calculation | At year 2 follow-up (estimated to be 2 years and 12 weeks) |
| Pathologic complete response rate (pCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Apicelli, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33604458 | Derived | Roy A, Gabani P, Davis EJ, Oppelt P, Merfeld E, Keedy VL, Zoberi I, Chrisinger JSA, Michalski JM, Van Tine B, Spraker MB. Concurrent paclitaxel and radiation therapy for the treatment of cutaneous angiosarcoma. Clin Transl Radiat Oncol. 2021 Jan 28;27:114-120. doi: 10.1016/j.ctro.2021.01.009. eCollection 2021 Mar. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Radiation therapy | Radiation | -Patients may be treated with electrons, 3D conformal photon radiotherapy, intensity modulated photon radiotherapy (IMRT), proton radiation therapy, or a combination of these. |
|
| Research blood draw | Procedure | -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 |
|
-Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist
| At the time of surgery (approximately 19 weeks) |
| Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0 | 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 | From 91 days through year 2 follow-up |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |