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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

Must not have

HIV-positive patients whose CD4+ T-cell count is < 350 cells/mcL

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV-positive with a CD4+ T-cell count below 350.

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I do not have brain metastases or central nervous system disease.

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I have moderate to severe nerve pain or damage.

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I do not have any uncontrolled illnesses like infections or heart problems.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) rate

Secondary study objectives

Overall survival (OS) rate

Pathologic complete response rate (pCR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Paclitaxel

2011

Completed Phase 4

~5450

Radiation therapy

2013

Completed Phase 3

~2850