A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
M.D. Anderson Cancer Center
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.
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 characte…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 * Histologically or cytologically confirmed stage IV cancer. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Candidate for LCT (radiation therapy +/- other local therapies such as surgery, ablation, or embolization) to all sites of progressive disease. * Progressive disease will be defined as a discrete radiologic lesion that has not received prior local therapy. Progressive disease will be defined as RECIST (v1.1) defined progression from pre-baseline imaging to baseline imaging at time of screening for the trial. * Progressive disease must r…
Interventions
- ProcedureLocal 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.
- ProcedureNext-line Systemic Therapy
The specific next-line systemic therapy will be determined by your doctor.
Location
- MD Anderson Cancer CenterHouston, Texas