OligoProgressive Metastatic Disease Clinical Trial
Official title:
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy.
Primary Objective: • To determine whether, in participants with oligoprogressive metastatic disease, LCT to all progressive sites of disease offers a benefit in PFS compared to NLST, across seven tumor types in a basket design. Secondary Objectives: - To determine whether LCT improves OS in participants with oligoprogressive disease across seven tumor types. - To assess safety/tolerability of LCT in participants with oligometastatic disease in tumor subtypes. - To compare quality of life (QOL) of LCT vs. next-line systemic therapy in participants with oligoprogressive disease. - To characterize duration and progression-free survival time of participants on same-line systemic therapy (SLST) after LCT in the experimental arm. - To identify predictive/prognostic biomarkers correlated with a benefit for LCT across tumor types, with the aim being to incorporate these biomarkers into future clinical trials. ;