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

ConditionMetastatic Disease
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • stereotactic radiation therapy in ablative doses to each metastatic site

    Radiation

    Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mtsOther 1 intervention

Trial outcomes

Primary outcomes

1

Treatment safety

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.

Time frame
End of years 1, 2, 3, 4, 5 (study completion)

Secondary outcomes

1

Effectiveness (PFS)

Progression-free survival, assessed in months

Time frame
From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.
2

Effectiveness (LC)

Local control for irradiated metastatic sites, assessed in months

Time frame
From the date of initiation until the date of documented radiological signs of metastasis relapse, assessed over a period of up to 60 months.
3

Effectiveness (OS)

Overall survival, assessed in months

Time frame
From the date of initiation until the date of death from any cause, assessed over a period of up to 60 months.
4

Time-to-CTX-change

Period of current drug line prolongation, assessed in months

Time frame
End of years 1, 2, 3, 4, 5 (study completion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Medical Research Radiological Centre of the Ministry of Health of Russia

Lead sponsor

Source ClinicalTrials.gov
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