Phase III Randomized Trial Comparing Standard Care With and Without Stereotactic Ablative Radiotherapy for Patients With Up to 10 Metastases and a Primary Tumor

What this Trial Is About

Researchers are evaluating a phase III randomized trial comparing standard care treatment alone to standard care plus Stereotactic Ablative Radiotherapy SABR for patients with up to 10 oligometastases and a synchronous primary tumor. Patients are assigned in a 12 ratio to either receive palliative radiotherapy or a combination of standard care and SABR. Participants are stratified based on cancer histology and number of metastases to better understand treatment outcomes. The trial includes two groups the standard arm receiving palliative radiotherapy aimed at symptom relief or preventing complications, and the experimental arm receiving treatment to both the primary tumor and metastases, with SABR preferred but other options like surgery, radiofrequency ablation, or fractionated radiation allowed if deemed better by oncologists. SABR doses typically range from 20 Gy in 1 fraction to 35 Gy in 5 fractions. Chemotherapy, hormone therapy, immunotherapy, targeted systemic therapy, or observation follow standard care approaches. Participants will undergo restaging imaging, performance status assessments, and monitoring for adverse effects over approximately six years. Researchers will measure overall survival as the primary outcome, with secondary outcomes including quality of life evaluations using FACT-G and EQ-5D-5L questionnaires, toxicity assessments by CTCAE, time to next systemic therapy, and receipt of additional radiation. Safety follow-up and detailed quality of life data collection take place mainly during the first two years of the study.

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.