OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia

About this trial

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

Qualifiers

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

Disqualifiers

ECOG status 4

De novo metastatic disease

Radiological complete response after drug therapy

Brain metastasis only

Trial design

Treatments tested in this trial

  • stereotactic radiation therapy in ablative doses to each metastatic site

Treatment groups

50 Participants
are divided into 1 treatment group