Study of Local Consolidation Therapy Compared to Next-Line Systemic Therapy for Adults with OligoProgressive Metastatic Cancer A Phase II Randomized Basket Trial

What this Trial Is About

Researchers are evaluating if local consolidation therapy LCT, including radiation therapy with or without other local treatments like surgery, ablation, or embolization, can better control oligoprogressive metastatic disease compared to next-line systemic therapy. This randomized Phase II basket trial focuses on patients with progressive cancer lesions across seven tumor types and aims to determine if LCT improves progression-free survival and overall survival while assessing safety, tolerability, quality of life, and biomarker correlations. Participants are randomly assigned to either receive next-line systemic therapy determined by their doctor or to receive LCT to all progressive disease sites followed by continuation of the same systemic therapy and, if needed, the next-line systemic therapy. The choice of LCT and radiation regimen is decided by a multidisciplinary team. Participants in the next-line systemic therapy group may cross over to receive LCT if their disease progresses. During the study, participants undergo imaging scans to identify progressive lesions suitable for treatment. Researchers monitor safety and adverse events for about one year. They also evaluate quality of life and disease progression through clinical exams and imaging. The study tracks treatment tolerability and collects data to identify biomarkers predicting benefit from LCT. Participation lasts until disease progression or study completion, with ongoing assessments throughout.

A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)