Clinical trial NCT03921008: Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma
Official title: Induction Paclitaxel Followed by Concurrent Paclitaxel and Radiation Therapy for Cutaneous Angiosarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cutaneous Angiosarcoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS) rate
timeFrame: At year 2 follow-up (estimated to be 2 years and 12 weeks)
Secondary outcomes:
measure: Overall survival (OS) rate
timeFrame: At year 2 follow-up (estimated to be 2 years and 12 weeks)
measure: Pathologic complete response rate (pCR)
timeFrame: At the time of surgery (approximately 19 weeks)
measure: Rate of acute treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0
timeFrame: From start of radiation through 90 days after start of radiation
measure: Rate of late treatment-related grade 3 or higher toxicity defined by CTCAE version 5.0
timeFrame: From 91 days through year 2 follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Anthony Apicelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.