Locally Advanced Soft Tissue Sarcoma Clinical Trial
Official title:
Phase 1b/2 Trial Using Neoadjuvant Lurbinectedin With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas of Extremity, Trunk, and Retroperitoneum
This is a multi-center, multi-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent lurbinectedin in combination with radiotherapy in patients with locally advanced, resectable, high-grade sarcomas.
PRIMARY OBJECTIVES: Phase Ib: I. To determine the safety and tolerability of neoadjuvant lurbinectedin - in combination with preoperative 2 weeks of hypofractionated radiation for extremity and trunk sarcoma, or - with 6 weeks of conventionally fractionated radiation for retroperitoneal sarcoma II. To determine the maximum tolerated dose (MTD) for neoadjuvant lurbinectedin in combination with preoperative external beam radiation therapy (EBRT) in patients with sarcoma. Phase II: I. To estimate the efficacy of neoadjuvant lurbinectedin in combination with preoperative EBRT (hypofractionated or conventionally fractionated), according to endpoint defined by sarcoma type and location: - Cohort 1: extremity and trunk sarcoma (HFRT) - Cohort 2: Extremity myxoid liposarcoma (HFRT) - Cohort 3: Retroperitoneal sarcoma (CFRT course) SECONDARY OBJECTIVES: I. Time to disease progression (local or distant recurrence). II. Overall response rate (ORR) pre-operative as measured by RECIST 1.1 or a later tool for monitoring disease progression. III. Overall survival. IV. To grade radiation related skin toxicity overlying the tumor area. V. To determine long term major wound healing complications with the use of this combination in all cohorts. EXPLORATORY OBJECTIVES: I. To evaluate changes in monocyte, macrophage, T cell, and RNA expression levels over time. OUTLINE: Participants will receive neoadjuvant lurbinectedin concurrent with radiation therapy. Non-investigational surgery will be performed 4-6 weeks from the end of radiation therapy. Participants with localized disease at the time of study enrollment will be on surveillance on-study for 2 years. Post-operatively participants will be followed every 12 +/- 4 weeks for approximately 2 years from the end of treatment. Participants with known metastatic disease will be followed until progression, toxicity and thereafter for 2 years. ;
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