Metastatic DiseasePhase 2OLIGO-10NCT06856603
OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
A Phase 2 study testing stereotactic radiation therapy in ablative doses to each metastatic site in people with Metastatic Disease, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Disease
- What is being tested?
- stereotactic radiation therapy in ablative doses to each metastatic site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 7 Feb 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, 249033
Konstantin Gordon, PhD, +79105184148, gordon@mrrc.obninsk.ru
Igor Gulidov, PhD
About this study
Official title: OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm 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.
Read the detailed description
- A patient with a previously verified diagnosis of a malignant neoplasm of any localization (ICD 10-11 codes C) who meets the inclusion criteria, after approval by the tumor board for the study group, will undergo the following procedures: Three-dimensional/four-dimensional computed tomography for simulation using specialized fixation devices (the choice of the CT method and fixation devices will depend on the location of the metastasis). The resulting images will be added to the contouring program. Delineation of targets and organs at risk will be performed. Clinical volumes and error margins will be determined.
- The total dose per target and dose limits for critical structures will be prescribed. Dosimetric planning for the course of external beam radiation therapy will be carried out. Irradiation sessions will be conducted on a linear accelerator with a multi-leaf collimator, including a function for visual control of the target using cone beam tomography with kilo-voltage/mega-voltage radiation. When the target is localized in the lungs, liver, or adrenal glands, to reduce the radiation load on surrounding healthy tissues and achieve necessary control over the position of the metastasis, irradiation will be performed with a deep breath hold or at specific phases of respiration.
- Tumor Localization / Description / Total Focal Dose (Gy) / Number of Fractions / Single Focal Dose (Gy) / Irradiation Mode: Lung Tumors: Tumors ≤ 3 cm located in the parenchyma: TD 45 Gy in 3 fractions with 15 Gy each day Tumors adjacent to the chest wall or < 3 cm: TD 50 Gy in 5 fractions with 10 Gy each day Tumors within 2 cm of the mediastinum or brachial plexus: TD 60 Gy in 8 fractions with 7.5 Gy each day Bones: TD 24 Gy in 3 fractions with 8 Gy each day Brain Metastases: Tumor volume from 0.5 to 5 cm³: TD 20-22 Gy in 1 fraction at a time Tumor volume from 5 to 10 cm³: TD 16-18 Gy or TD 18-20 Gy in 1 fraction at a time Liver: Radiation regimen selection based on the tolerance of surrounding tissues and proximity to critical structures: TD 30-60 Gy in 3-8 fractions with 6-15 Gy each day Adrenal Glands: TD 60 Gy in 8 fractions with 7.5 Gy each day
- Expected Duration of Patient Participation in Clinical Testing:
Pre-hospital period: Comprehensive examination of the patient before treatment. Inpatient period: Includes pre-radiation preparation for up to 3 working days, SABR treatment for 1 to 8 working days.
Follow-up period: 3, 6, 9, and 12 months post-treatment; thereafter, follow-up will occur every 6 months up to 60 months.
Collection and processing of received data.
- Conditions
- Metastatic Disease
- Being tested
- stereotactic radiation therapy in ablative doses to each metastatic site
- Keywords
- Metastatic Disease, Stereotactic radiation therapy, Stereotactic body radiation therapy, Stereotactic ablative radiation therapy, Oligometastatic Disease
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiation therapy in ablative doses to each metastatic siteRadiation
Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).
| Study group | Role | What they receive |
|---|---|---|
| A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts | Other | 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. Receives: Radiation: stereotactic radiation therapy in ablative doses to each metastatic site |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of years 1, 2, 3, 4, 5 (study completion)
Secondary outcomes (4)
Effectiveness (PFS)
Progression-free survival, assessed in months
Measured: From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.
Effectiveness (LC)
Local control for irradiated metastatic sites, assessed in months
Measured: From the date of initiation until the date of documented radiological signs of metastasis relapse, assessed over a period of up to 60 months.
Effectiveness (OS)
Overall survival, assessed in months
Measured: From the date of initiation until the date of death from any cause, assessed over a period of up to 60 months.
Time-to-CTX-change
Period of current drug line prolongation, assessed in months
Measured: End of years 1, 2, 3, 4, 5 (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start7 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SABR for Extra- and Intracranial Metastatic Disease with 6-10 Sites
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin Gordon, National Medical Research Radiological Centre of the Ministry of Health of Russia
- Investigators
- Andrey Kaprin, PhD, Study chair, National Medical Research Radiological Centre of the Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856603
- Sponsor's protocol ID
- 2024_06_13
- Acronym
- OLIGO-10
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request from the principal investigator for researchers, who meet the criteria for access to confidential data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial
- ClinicalTrials.gov ID
- NCT06856603
- Acronym / sponsor ID
- OLIGO-10 / 2024_06_13
- Conditions
- Metastatic Disease
- Keywords
- Metastatic Disease, Stereotactic radiation therapy, Stereotactic body radiation therapy, Stereotactic ablative radiation therapy, Oligometastatic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- A patient with a previously verified diagnosis of a malignant neoplasm of any localization (ICD 10-11 codes C) who meets the inclusion criteria, after approval by the tumor board for the study group, will undergo the following procedures: Three-dimensional/four-dimensional computed tomography for simulation using specialized fixation devices (the choice of the CT method and fixation devices will depend on the location of the metastasis). The resulting images will be added to the contouring program. Delineation of targets and organs at risk will be performed. Clinical volumes and error margins will be determined.
- The total dose per target and dose limits for critical structures will be prescribed. Dosimetric planning for the course of external beam radiation therapy will be carried out. Irradiation sessions will be conducted on a linear accelerator with a multi-leaf collimator, including a function for visual control of the target using cone beam tomography with kilo-voltage/mega-voltage radiation. When the target is localized in the lungs, liver, or adrenal glands, to reduce the radiation load on surrounding healthy tissues and achieve necessary control over the position of the metastasis, irradiation will be performed with a deep breath hold or at specific phases of respiration.
- Tumor Localization / Description / Total Focal Dose (Gy) / Number of Fractions / Single Focal Dose (Gy) / Irradiation Mode: Lung Tumors: Tumors ≤ 3 cm located in the parenchyma: TD 45 Gy in 3 fractions with 15 Gy each day Tumors adjacent to the chest wall or < 3 cm: TD 50 Gy in 5 fractions with 10 Gy each day Tumors within 2 cm of the mediastinum or brachial plexus: TD 60 Gy in 8 fractions with 7.5 Gy each day Bones: TD 24 Gy in 3 fractions with 8 Gy each day Brain Metastases: Tumor volume from 0.5 to 5 cm³: TD 20-22 Gy in 1 fraction at a time Tumor volume from 5 to 10 cm³: TD 16-18 Gy or TD 18-20 Gy in 1 fraction at a time Liver: Radiation regimen selection based on the tolerance of surrounding tissues and proximity to critical structures: TD 30-60 Gy in 3-8 fractions with 6-15 Gy each day Adrenal Glands: TD 60 Gy in 8 fractions with 7.5 Gy each day
- Expected Duration of Patient Participation in Clinical Testing:
Pre-hospital period: Comprehensive examination of the patient before treatment. Inpatient period: Includes pre-radiation preparation for up to 3 working days, SABR treatment for 1 to 8 working days.
Follow-up period: 3, 6, 9, and 12 months post-treatment; thereafter, follow-up will occur every 6 months up to 60 months.
Collection and processing of received data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SABR for Extra- and Intracranial Metastatic Disease with 6-10 Sites
| Arm | Type | Receives |
|---|---|---|
| A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts | Other | Radiation: stereotactic radiation therapy in ablative doses to each metastatic siteThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- ECOG status 4
- De novo metastatic disease
- Radiological complete response after drug therapy
- Brain metastasis only
- Brain metastasis > 3 cm, requiring neurosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiation therapy in ablative doses to each metastatic siteStereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease). | Radiation | A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts |
Primary outcome
Treatment safety
Time frame: End of years 1, 2, 3, 4, 5 (study completion)
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.
4 secondary outcomes
Effectiveness (PFS)
Time frame: From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.
Effectiveness (LC)
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.
Effectiveness (OS)
Time frame: From the date of initiation until the date of death from any cause, assessed over a period of up to 60 months.
Time-to-CTX-change
Time frame: End of years 1, 2, 3, 4, 5 (study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes. Data will be available upon request from the principal investigator for researchers, who meet the criteria for access to confidential data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrey Kaprin, PhD study chair
National Medical Research Radiological Centre of the Ministry of Health of Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic radiation therapy in ablative doses to each metastatic site in people with Metastatic Disease, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantin gordon, PhD (0079105184148, dr_gordon@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment safety (time frame: End of years 1, 2, 3, 4, 5 (study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.