Actively Recruiting
OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
Led by National Medical Research Radiological Centre of the Ministry of Health of Russia · Updated on 2025-03-04
50
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG status 0-3
- Persistent or progressive cancer disease with 6 to 10 metastases
- Five or fewer metastases in any single organ
- Life expectancy greater than 6 months for intracranial lesions
- Unable to surgically remove all metastatic lesions
- Positive tumor board decision for trial inclusion
- Signed informed consent
You will not qualify if you...
- ECOG status 4
- Newly diagnosed metastatic disease (de novo)
- Complete response on imaging after drug therapy
- Only brain metastases present
- Brain metastasis larger than 3 cm requiring neurosurgery
- Any metastasis larger than 5 cm
- Previous radiation therapy for metastatic sites
- Presence of leptomeningeal, pleural, or peritoneal carcinomatosis
- Spinal cord compression requiring neurosurgery
- Invasion of major blood vessels, skin, or gastrointestinal tract
- Negative tumor board decision for trial inclusion
- Lack of signed informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, Russia, 249033
Actively Recruiting
Research Team
K
Konstantin gordon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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