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COG-NRG ARST1321

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 Investigators

COG: Aaron Weiss, DO

NRG Oncology: Yen-Lin Chen, MD

 Primary Objectives

  • 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 portion of 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

  • Stage T2a/b (> 5 cm) and Grade 3 (see Appendix III); One of the following chemosensitive histologies as defined inNewly 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

Status

Activated July 11, 2014

Protocol Documents

Available via the NCI Cancer Trails Support Unit (CTSU) web site: www.ctsu.org

Copyright 2017 by NRG Oncology