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

Last updated: December 3, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer/tumors

Soft Tissue Sarcoma

Treatment

Radiation therapy

Paclitaxel

Research blood draw

Clinical Study ID

NCT03921008
201904069
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed cutaneous angiosarcoma.

  • Measurable disease defined as lesions that can be accurately measured in at leastone dimension (longest diameter to be recorded) as ≥ 5 mm with CT scan or ≥ 5 mm byclinical exam at the time of diagnosis

  • Currently receiving or planning to receive weekly paclitaxel for 12 weeks at 80mg/m^2 weekly. The patient must be able to begin radiotherapy within the first 7weeks 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 andfor the duration of study participation. Should a woman become pregnant or suspectshe is pregnant while participating in this study, she must inform her treatingphysician immediately. Men treated or enrolled on this protocol must also agree touse adequate contraception prior to the study, for the duration of the study, andone month after completion of the study

  • Ability to understand and willingness to sign an IRB approved written informedconsent document (or that of legally authorized representative, if applicable).

Exclusion

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 orsquamous cell carcinoma of the skin which were treated with local resection only orcarcinoma in situ of the cervix.

  • Currently receiving any investigational agents.

  • Current central nervous system disease or distant metastatic disease not includinglocal-regional lymph nodes or satellite lesions. Patients with known brainmetastases must be excluded from this clinical trial because of their poor prognosisand because they often develop progressive neurologic dysfunction that wouldconfound the evaluation of neurologic and other adverse events.

  • Grade 2 or greater neuropathy

  • A history of allergic reactions attributed to compounds of similar chemical orbiologic composition to paclitaxel or other agents used in the study.

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, orcardiac arrhythmia.

  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negativepregnancy test within 14 days of study entry.

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

Study Design

Total Participants: 19
Treatment Group(s): 3
Primary Treatment: Radiation therapy
Phase: 1/2
Study Start date:
May 21, 2019
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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