NCT06367972

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• OligoProgressive Metastatic Disease

Interventions

Type	Name	Description
PROCEDURE	Local Consolidation Therapy	Participants may receive radiation therapy. The choice of LCT and radiation therapy regimen will be determined by a multidisciplinary team including the study doctor.
PROCEDURE	Next-line Systemic Therapy	The specific next-line systemic therapy will be determined by your doctor.

Timeline

• Start date: 2024-06-06
• Primary completion: 2028-10-10
• Completion: 2030-10-10
• First posted: 2024-04-16
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States