RecruitingPhase 1NCT06025747

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

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


Sponsor

University of Washington

Enrollment

18 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called abemaciclib (a targeted cancer therapy) to radiation therapy before surgery can shrink a rare and aggressive type of fat-tissue cancer called high-risk dedifferentiated retroperitoneal sarcoma. This cancer grows behind the abdominal organs and is hard to treat. The goal is to make surgery more effective by treating the tumor first. **You may be eligible if...** - You are 18 or older with a newly diagnosed or locally recurrent retroperitoneal fat-tissue sarcoma (adipocytic sarcoma) with specific genetic features (MDM2 or CDK4 amplification) - Your tumor is considered removable with surgery - You are otherwise in good health with adequate blood counts, kidney, and liver function **You may NOT be eligible if...** - You have already received chemotherapy or radiation for this cancer - Your cancer has spread to distant parts of the body - You have a recent blood clot history (within 1 year) - You have a history of serious heart rhythm problems or sudden cardiac arrest - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Given PO

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

RADIATIONRadiation Therapy

Undergo radiation therapy

PROCEDURETherapeutic Surgical Procedure

Undergo surgery


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT06025747


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