OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites
NCT ID: NCT06856603
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-02-07
2030-12-31
Brief Summary
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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.
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Detailed Description
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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.
2. 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.
3. 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
4. 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A single-arm: Stereotactic Ablative Radiotherapy (SABR) for 6-10 mts
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.
stereotactic radiation therapy in ablative doses to each metastatic site
Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).
Interventions
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stereotactic radiation therapy in ablative doses to each metastatic site
Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Medical Research Radiological Centre of the Ministry of Health of Russia
OTHER
Responsible Party
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Konstantin Gordon
Principal Investigator
Principal Investigators
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Andrey Kaprin, PhD
Role: STUDY_CHAIR
National Medical Research Radiological Centre of the Ministry of Health of Russia
Locations
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A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024_06_13
Identifier Type: -
Identifier Source: org_study_id
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