Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiation therapy in ablative doses to each metastatic site | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts
- description
- The method of stereotactic ablative radiation therapy will be used in patients with metastatic tumors (6-10 sites) of various localizations, following the current line of chemotherapy (T1-4, N0-3, M0-1), and who are over 18 years old at the time of treatment initiation.
- interventionNames
- Radiation: stereotactic radiation therapy in ablative doses to each metastatic site
Primary outcomes (1)
- measure
- Treatment safety
- timeFrame
- End of years 1, 2, 3, 4, 5 (study completion)
- description
- Radiation-induced toxicity (type and corresponding grade 1 to 5) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available