Soft Tissue Sarcoma Treatment with Preoperative Radiation and Pazopanib (PAZNTIS Trial) – Phase II/III

Pazopanib Neoadjuvunt Trial on Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib

Protocol Description

The PAZNTIS multicenter trial by the Children’s Oncology Group studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work in treating young patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). In adults with certain NRSTS, pazopanib has been shown to have anti-tumor effects.

Study Level: Phase II/III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to pediatric patients of both genders, age 2 or greater, who have been newly diagnosed with an intermediate- or high-risk NRSTS that could not be removed by surgery at the time of diagnosis.
Males and Females: Ages 2 years and up

Requirements

For this study, participants will receive oral doses of pazopanib along with standard chemotherapy for the 12-week induction phase. If the tumor has responded to therapy, it will be removed by surgery and the patient will advance to the 9-week continuation phase, during which the study drug will continue to be provided with chemotherapy, possibly supported by radiation therapy and additional surgery.
Visits: Same number as required for standard chemotherapy
Duration: About 6 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ARST1321)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean Tersak, MD
412-692-5055