Spots Global Cancer Trial Database for Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities

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Trial Identification

Brief Title: Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities

Official Title: A Phase 1/2 Study of Neoadjuvant Cabozantinib in Combination With Radiation Therapy for Sarcomas of the Extremities

Study ID: NCT04220229

Conditions

Sarcoma of the Extremity

Stage I Soft Tissue Sarcoma of the Trunk and Extremities

Stage IA Soft Tissue Sarcoma of the Trunk and Extremities

Stage IB Soft Tissue Sarcoma of the Trunk and Extremities

Stage II Soft Tissue Sarcoma of the Trunk and Extremities

Interventions

Cabozantinib S-malate

Radiation Therapy

Study Description

Brief Summary: This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cabozantinib with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.

Detailed Description: OUTLINE: This is a phase I, dose-escalation study of cabozantinib followed by a phase II, dose-expansion study. Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning Cycle 1 Day 8, patients also undergo standard of care radiation therapy for 5-6 weeks. After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, then every 6 months for up to 3 years.