Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

Summary

This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.

Conditions

• Alveolar Soft Part Sarcoma
• Angiomatoid Fibrous Histiocytoma
• Atypical Fibroxanthoma
• Clear Cell Sarcoma of Soft Tissue
• Epithelioid Malignant Peripheral Nerve Sheath Tumor
• Epithelioid Sarcoma
• Extraskeletal Myxoid Chondrosarcoma
• Extraskeletal Osteosarcoma
• Fibrohistiocytic Neoplasm
• Fibrosarcoma
• Inflammatory Myofibroblastic Tumor
• Intimal Sarcoma
• Leiomyosarcoma
• Liposarcoma
• Liver Embryonal Sarcoma
• Low Grade Fibromyxoid Sarcoma
• Low Grade Myofibroblastic Sarcoma
• Malignant Peripheral Nerve Sheath Tumor
• Malignant Skin Granular Cell Tumor
• Malignant Triton Tumor
• Mesenchymal Chondrosarcoma
• Myxofibrosarcoma
• Myxoid Chondrosarcoma
• Myxoinflammatory Fibroblastic Sarcoma
• Nerve Sheath Neoplasm
• PEComa
• Pericytic Neoplasm
• Plexiform Fibrohistiocytic Tumor
• Sclerosing Epithelioid Fibrosarcoma
• Skin Glomus Tumor
• Stage IB Soft Tissue Sarcoma AJCC v7
• Stage IIB Soft Tissue Sarcoma AJCC v7
• Stage III Soft Tissue Sarcoma AJCC v7
• Stage IV Soft Tissue Sarcoma AJCC v7
• Synovial Sarcoma
• Undifferentiated High Grade Pleomorphic Sarcoma of Bone

Interventions

DRUG

Doxorubicin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Pazopanib

Given PO

DRUG

Pazopanib Hydrochloride

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Aaron R Weiss · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-11

Primary Completion

2019-06-30

Completion

2026-12-24

Countries

• United States
• Canada
• Puerto Rico

Study Locations