OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial
National Medical Research Radiological Centre of the Ministry of Health of Russia
50 participants
Feb 7, 2025
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06856603