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.