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Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma

Retroperitoneal Sarcoma Clinical Trial

Official title:
A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas

Clinical Trial Summary

This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.

Clinical Trial Description

OUTLINE: This is a dose-escalation study of abemaciclib. Prior to surgery, patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy over 28 fractions starting on cycle 1 day 15 in the absence of disease progression or unacceptable toxicity. After completion of radiation therapy, patients may undergo surgery. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study. After completion of study treatment, patients are followed up at 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06025747
Study type Interventional
Source University of Washington
Contact Roxanne Moore
Phone 206-606-6425
Email sarcomaresearch@fredhutch.org
Status Not yet recruiting
Phase Phase 1
Start date July 1, 2024
Completion date March 3, 2026
View Details
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