Stereotactic radiation therapy for 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
This study is testing a new type of targeted radiation therapy for people with metastatic cancer who have 6 to 10 tumor sites to see if it can help them live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Medical Research Radiological Centre of the Ministry of Health of Russia Academic / other |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 1 site (Obninsk, Kaluga Oblast) |
| Trial ID | NCT06856603 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of stereotactic ablative radiation therapy in patients with metastatic cancer who have between 6 to 10 metastatic sites. Patients will undergo advanced imaging and dosimetric planning to target their tumors with high precision radiation. The treatment aims to improve overall survival in a patient population that has not been extensively studied in previous trials. The approach is based on emerging evidence suggesting benefits of radiation therapy in oligometastatic disease.
Who should consider this trial
Good fit: Ideal candidates include patients with persistent or progressive cancer disease and 6 to 10 metastases who are not eligible for surgical resection.
Not a fit: Patients with ECOG status 4, de novo metastatic disease, or those who have had previous radiation therapy for any metastatic site may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with multiple metastatic sites.
How similar studies have performed: Other studies have shown success with stereotactic ablative radiation therapy for fewer metastatic sites, but this specific approach for 6 to 10 metastases is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Obninsk, Kaluga Oblast
- A. Tsyb Medical Radiological Research Center — Obninsk, Kaluga Oblast, Russia (Recruiting)
Study contacts
- Study coordinator: Konstantin gordon, PhD
- Email: dr_gordon@yahoo.com
- Phone: 0079105184148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.