Phase 1 Study Evaluating Abemaciclib with Radiation Therapy Before Surgery in High-Risk Adipocytic Retroperitoneal Sarcoma

What this Trial Is About

Researchers are evaluating the safety, side effects, and optimal dose of abemaciclib combined with radiation therapy before surgery in patients with high-risk adipocytic retroperitoneal sarcoma. This phase I trial focuses on how abemaciclib may block enzymes needed for tumor growth and how radiation therapy can shrink tumors. The study aims to determine how well this combination works for patients with this rare type of sarcoma. Participants receive abemaciclib orally twice daily for 28 days, repeating this cycle up to three times if the disease does not progress or toxicity is unacceptable. Radiation therapy is given in 28 sessions starting midway through the first cycle. After completing radiation, patients may have surgery to remove the tumor. Imaging scans like CT or MRI are performed during screening and throughout the study. During the trial, participants undergo regular assessments including scans and laboratory tests to monitor tumor response and safety. Researchers track the dose recommendation, pathologic response rate, surgery success, adverse events, and treatment discontinuation. Follow-up occurs 30 days after treatment ends to evaluate participant health and outcomes.

A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas