COG-NRG ARST1321

Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS):  A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC#737754; IND#118613)

Principal Investigator

Aaron Weiss

Status

Disease Site

Other [DT] Sarcoma

Phase

II/III

Developmental Therapeutics

No

Primary Objective

 
• To identify the dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and- high-risk NRSTS.

 

• To compare the rates of near complete pathologic response (>90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable >5 cm, Grade 3 intermediate to high risk chemotherapy-sensitive NRSTS in the Phase II portion of the study for this cohort.

 

• To compare the rates of near complete pathologic response (>90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the Phase II portion of the study for this cohort (using a Phase II decision rule to go onto the Phase III portio nof the study).

 

• To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the Phase III portion of the study for this cohort if the Phase II decision rule is passed.

Patient Population

Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:

 
• Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials;

 

• Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade; and

 

• Medically deemed able or unable to undergo chemotherapy.

 

Target Accrual

340