Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma
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ClinicalTrials.gov Identifier: NCT03921008 |
Recruitment Status :
Recruiting
First Posted : April 19, 2019
Last Update Posted : August 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cutaneous Angiosarcoma | Drug: Paclitaxel Radiation: Radiation therapy Procedure: Research blood draw | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma |
Actual Study Start Date : | May 21, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | May 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Paclitaxel and Radiation
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Drug: Paclitaxel
-Commercial supply
Other Name: Taxol Radiation: Radiation therapy -Patients may be treated with electrons, 3D conformal photon radiotherapy, intensity modulated photon radiotherapy (IMRT), proton radiation therapy, or a combination of these. Procedure: Research blood draw -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 |
- Progression-free survival (PFS) rate [ Time Frame: 2 years following enrollment ]
- 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.
- Overall survival (OS) rate [ Time Frame: At 2 years following enrollment ]-Patients that have died from any cause will be censored from the OS rate calculation
- Pathologic complete response rate (pCR) [ Time Frame: At the time of surgery (approximately 19 weeks) ]-Defined as the lack of viable cells observed in resected tumor tissue following neoadjuvant therapy and will be determined by an experienced sarcoma pathologist
- Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0 [ Time Frame: Through 90 days of completing treatment ]
- Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0 [ Time Frame: At 2 years following enrollment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed cutaneous angiosarcoma.
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 5 mm with CT scan or ≥ 5 mm by clinical exam at the time of diagnosis
- Currently receiving or planning to receive weekly paclitaxel for 12 weeks at 80 mg/m^2 weekly. The patient must be able to begin radiotherapy within the first 7 weeks of paclitaxel treatment.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and one month after completion of the study
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon.
- A history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any investigational agents.
- Current central nervous system disease or distant metastatic disease not including local-regional lymph nodes or satellite lesions. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Grade 2 or greater neuropathy
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- HIV-positive patients whose CD4+ T-cell count is < 350 cells/mcL.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921008
Contact: Matthew Spraker, M.D. | 314-362-8567 | mspraker@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Matthew Spraker, M.D. 314-362-8567 mspraker@wustl.edu | |
Principal Investigator: Matthew Spraker, M.D. | |
Sub-Investigator: Prashant Gabani, M.D. | |
Sub-Investigator: Brian Van Tine, M.D., Ph.D. | |
Sub-Investigator: Ryan Jackson, M.D. | |
Sub-Investigator: Jason Rich, M.D. | |
Sub-Investigator: Brian Baumann, M.D. | |
Sub-Investigator: Jeff Michalski, M.D., M.B.A | |
Sub-Investigator: Imran Zoberi, M.D. | |
Sub-Investigator: Leping Wan, M.P.H. |
Principal Investigator: | Matthew Spraker, M.D. | Washington University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03921008 |
Other Study ID Numbers: |
201904069 |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | August 19, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Hemangiosarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Paclitaxel |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |