Condition or disease | Intervention/treatment | Phase |
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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, 2024 |
Estimated Study Completion Date : | May 31, 2024 |
Arm | Intervention/treatment |
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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
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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:
Exclusion Criteria:
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 |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 16, 2019 | ||||||
First Posted Date ICMJE | April 19, 2019 | ||||||
Last Update Posted Date | May 26, 2021 | ||||||
Actual Study Start Date ICMJE | May 21, 2019 | ||||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression-free survival (PFS) rate [ Time Frame: 2 years following enrollment ]
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma | ||||||
Official Title ICMJE | Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cutaneous Angiosarcoma | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Paclitaxel and Radiation
Interventions:
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
19 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 31, 2024 | ||||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03921008 | ||||||
Other Study ID Numbers ICMJE | 201904069 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Washington University School of Medicine | ||||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Washington University School of Medicine | ||||||
Verification Date | May 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |