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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Sarcoma
  • 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

NCT number NCT04220229
Study type Interventional
Source University of Washington
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 1, 2020
Completion date January 23, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05526417 - Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma N/A