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Anti-microtubule agent

Chemotherapy and Radiation for Cutaneous Angiosarcoma

Phase 1 & 2

Recruiting

Led By Matthew Spraker, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at year 2 follow-up (estimated to be 2 years and 12 weeks)

Awards & highlights

Study Summary

This trial looks at whether giving chemotherapy and radiation before surgery can improve outcomes for people with a rare and aggressive form of soft tissue sarcoma.

Who is the study for?

This trial is for adults with measurable cutaneous angiosarcoma, a rare skin cancer. They must be fit enough for treatment (ECOG ≤1), agree to use contraception, and not have other recent cancers except certain skin cancers or cervical carcinoma in situ. Participants need to start radiotherapy within the first 7 weeks of weekly paclitaxel chemotherapy.Check my eligibility

What is being tested?

The study tests induction paclitaxel followed by concurrent chemoradiation therapy before surgical removal of the tumor. It aims to see if this approach improves outcomes in patients with localized disease who are typically treated with surgery alone.See study design

What are the potential side effects?

Paclitaxel may cause side effects like allergic reactions, nerve damage (neuropathy), fatigue, hair loss, muscle pain, and increased risk of infection. Radiation therapy might lead to skin irritation at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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I am starting or already on a weekly paclitaxel treatment and can start radiotherapy within 7 weeks of it.

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I am 18 years old or older.

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My cancer is a skin angiosarcoma confirmed by lab tests.

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My cancer can be measured and is at least 5 mm in size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at year 2 follow-up (estimated to be 2 years and 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at year 2 follow-up (estimated to be 2 years and 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at year 2 follow-up (estimated to be 2 years and 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) rate

Secondary outcome measures

Overall survival (OS) rate

Pathologic complete response rate (pCR)

Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Paclitaxel and RadiationExperimental Treatment3 Interventions

All patients will receive standard of care induction chemotherapy with 6 weekly cycles of paclitaxel at 80 mg/m^2. They will then receive 6 weekly cycles of paclitaxel at 80 mg/m^2 concurrently with radiation therapy. Patients will be receiving paclitaxel as part of their routine care, but in order to participate in this study, their induction chemotherapy regimen must be paclitaxel. Radiation therapy is 50.4 Gy in 28 fractions delivered within 7 weeks. Standard of care surgery ideally within 6 weeks after completing concurrent chemotherapy and radiation therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Research blood draw

2022

Completed Phase 2

~240

Paclitaxel

2011

Completed Phase 4

~5380

Radiation therapy

2013

Completed Phase 3

~2850

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,737 Total Patients Enrolled

Matthew Spraker, M.D.Principal InvestigatorWashington University School of Medicine

Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

357 Total Patients Enrolled

Media Library

Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT03921008 — Phase 1 & 2

Cutaneous Angiosarcoma Research Study Groups: Paclitaxel and Radiation

Cutaneous Angiosarcoma Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT03921008 — Phase 1 & 2

Paclitaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03921008 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prior investigations involving Paclitaxel?

"Currently, there are 832 active clinical trials investigating Paclitaxel. Of these experiments, 227 have reached Phase 3. While the majority of experimentation is occurring in Melbourne, Victoria; a total of 45681 sites around the world are conducting research on this drug."

Answered by AI

What maladies can Paclitaxel be utilized to address?

"Paclitaxel is commonly prescribed for neoplasm metastasis, but it may also be used to treat kaposi sarcoma, fallopian tube cancer, and even aid in advanced directives."

Answered by AI

Are there any vacancies available in this experiment for participants?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was posted on May 21st 2019, is currently recruiting patients. 19 individuals are needed from one single medical centre to participate in the study."

Answered by AI

What is the upper limit for patient participation in this experiment?

"Confirmed. The clinicaltrials.gov database corroborates that this investigation is actively seeking participants, starting from May 21st 2019 and last amended on July 11th 2022. 19 patients are needed at a single medical centre for the duration of the study."

Answered by AI

Recent research and studies

Clinical and Translational Radiation OncologyJournal

Concurrent Paclitaxel and Radiation Therapy for the Treatment of Cutaneous Angiosarcoma

Roy, Amit, Prashant Gabani, Elizabeth J. Davis, Peter Oppelt, Emily Merfeld, Vicky L. Keedy, Imran Zoberi, et al.. 2021. “Concurrent Paclitaxel and Radiation Therapy for the Treatment of Cutaneous Angiosarcoma”. Clinical and Translational Radiation Oncology. Elsevier BV. doi:10.1016/j.ctro.2021.01.009.

clinicaltrials.govStudy

Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma

2019. "Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03921008.

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