Pancreatic Cancer Research

Clinical trialPhase 2 / Phase 3Recruiting

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

Outcome
Ongoing
Phase
Phase 2 / Phase 3
Status
Recruiting
Study type
Interventional
Start
6 June 2024
Expected end
10 October 2030
Enrollment
400 participants
Sites
1
Primary outcomes
Safety and adverse events (AEs)
Sponsor
Other
Results posted
No
Last update
11 June 2026

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.