Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Patients receive cabozantinib S-malate PO 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.

Cabozantinib S-malate

Undergo standard of care radiation therapy

Radiation Therapy

Lee Cranmer

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.

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.

Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities

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

Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities	NCT04220229	Sarcoma of the ... Stage I Soft Ti... Stage IA Soft T... Stage IB Soft T... Stage II Soft T...	Cabozantinib S-... Radiation Thera...	18 Years -	University of Washington
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities	NCT04220229	Sarcoma of the ... Stage I Soft Ti... Stage IA Soft T... Stage IB Soft T... Stage II Soft T...	Cabozantinib S-... Radiation Thera...	18 Years -	University of Washington
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities	NCT04220229	Sarcoma of the ... Stage I Soft Ti... Stage IA Soft T... Stage IB Soft T... Stage II Soft T...	Cabozantinib S-... Radiation Thera...	18 Years -	University of Washington

Spots Global Cancer Trial Database for sarcoma of the extremity