NCT06856603 OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
| NCT ID | NCT06856603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Medical Research Radiological Centre of the Ministry of Health of Russia |
| Condition | Metastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-02-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Andrey Kaprin, PhD
STUDY CHAIR
National Medical Research Radiological Centre of the Ministry of Health of Russia
Frequently Asked Questions
Who can join the NCT06856603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06856603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06856603 currently recruiting?
Yes, NCT06856603 is actively recruiting participants. Contact the research team at dr_gordon@yahoo.com for enrollment information.
Where is the NCT06856603 trial being conducted?
This trial is being conducted at Obninsk, Russia.
Who is sponsoring the NCT06856603 clinical trial?
NCT06856603 is sponsored by National Medical Research Radiological Centre of the Ministry of Health of Russia. The principal investigator is Andrey Kaprin, PhD at National Medical Research Radiological Centre of the Ministry of Health of Russia. The trial plans to enroll 50 participants.