OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
NCT06856603
Summary
Currently, the standard of care for patients with diagnosed metastatic cancer is drug therapy (chemotherapy, targeted therapy, or immunotherapy). However, the approach to oligometastatic disease (1-5 metastases) is evolving. An increasing number of de novo, persistent, and progressive oligometastatic tumors are now being treated with curative intent, with radiation therapy among the most effective treatment options, applied to metastatic sites in ablative doses. Emerging results from the SABR-COMET 3 and 5 trials, which investigate stereotactic ablative radiotherapy for patients with 1-3 and 1-5 metastatic sites, demonstrate a clear improvement in overall survival. However, patients with more than five metastases remain in a gray area. The aim of our study is to assess the safety and effectiveness of radiation treatment for patients with tumors of various localizations and 6 to 10 metastases in the bones and internal organs. Stereotactic radiation therapy will be applied to patients with persistent or progressive metastatic forms of tumors, without changing their ongoing drug therapy regimen.
Eligibility
Inclusion Criteria: * ECOG status 0-3 * Persistent or progressive cancer disease with 6 to 10 metastases * ≤ 5 metastases in one organ * Life expectancy \> 6 months for intracranial lesions * Inability to surgically resect all metastatic lesions * Positive tumor board decision for trial inclusion * Signed informed consent Exclusion Criteria: * ECOG status 4 * De novo metastatic disease * Radiological complete response after drug therapy * Brain metastasis only * Brain metastasis \> 3 cm, requiring neurosurgery * Size of any metastasis \> 5 cm * Previous radiation therapy for any metastatic site * Leptomeningeal, pleural, or peritoneal carcinomatosis * Spinal cord compression, requiring neurosurgery * Invasion of great vessels, skin, or GI tract * Negative tumor board decision for trial inclusion * Unsigned informed consent
Conditions2
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06856603