OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
Recruiting now · Phase 2
Conditions studied: Metastatic Disease
In brief
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.
Key facts
- Study ID
- NCT06856603
- Run by
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- People needed
- 50
- Starts
- 2025-02-07
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- A. Tsyb Medical Radiological Research Center — Obninsk, Kaluga Oblast, Russia (enrolling)
Full record on ClinicalTrials.gov
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