NCT Number: NCT06856603
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Obninsk, Kaluga Oblast, 249033, Russia
Location status: Recruiting
Daniil Smyk, PhD
SUB_INVESTIGATOR
Igor Gulidov, PhD
PRINCIPAL_INVESTIGATOR
Konstantin Gordon, PhD
CONTACT
Konstantin Gordon, PhD
SUB_INVESTIGATOR
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.
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.
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stereotactic ablative radiation therapy will be utilized for each metastatic site in patients with 6 to 10 sites of metastasis (persistent or progressive disease).
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.
Time frame: From the date of initiation until the date of documented disease progression, assessed over a period of up to 60 months.
Progression-free survival, 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.
Local control for irradiated metastatic sites, 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.
Overall survival, assessed in months
Time frame: End of years 1, 2, 3, 4, 5 (study completion)
Period of current drug line prolongation, assessed in months
Contact information is provided by the study sponsor or research team.
National Medical Research Radiological Centre of the Ministry of Health of Russia
Other
OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial
Acronym: OLIGO-10
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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