NCT02050919

Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma

A Phase II Study of Sorafenib With Chemotherapy, Radiation, and Surgery for High-Risk Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride and ifosfamide, 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. Radiation therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue sarcoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the pathologic response rate (\>= 95% necrosis) after preoperative treatment with sorafenib (sorafenib tosylate), epirubicin (epirubicin hydrochloride), ifosfamide, and hypofractionated radiation for high risk soft tissue sarcomas of the extremities or body wall. SECONDARY OBJECTIVES: I. To further characterize the safety of sorafenib plus chemoradiotherapy, including wound complication rate. II. To estimate time-to-event rates, including overall survival, overall disease-free survival, distant disease-free survival, and local disease-free survival in patients with high risk soft tissue sarcomas of the extremities or body wall treated with preoperative sorafenib plus chemoradiotherapy and postoperative sorafenib plus chemotherapy. OUTLINE: Patients receive sorafenib tosylate orally (PO) once daily (QD) on days 1-71 and 85-155, epirubicin hydrochloride intravenously (IV) over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo external beam radiation therapy (EBRT) on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

Conditions

• Pleomorphic Rhabdomyosarcoma
• Stage IIB Adult Soft Tissue Sarcoma AJCC v7
• Stage III Adult Soft Tissue Sarcoma AJCC v7
• Stage IV Adult Soft Tissue Sarcoma AJCC v7

Interventions

Type	Name	Description
DRUG	Epirubicin Hydrochloride	Given IV
RADIATION	External Beam Radiation Therapy	Undergo EBRT
DRUG	Ifosfamide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sorafenib Tosylate	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgical resection

Timeline

• Start date: 2013-12-03
• Primary completion: 2018-05-07
• Completion: 2020-12-31
• First posted: 2014-01-31
• Last updated: 2022-03-21
• Results posted: 2020-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study