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Recruiting Phase 2, Phase 3 NCT06556550

Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care

Trial Parameters

Condition Oligometastatic Disease
Sponsor National Medical Research Radiological Centre of the Ministry of Health of Russia
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-31
Completion 2028-12-31
Interventions
stereotactic ablative radiation therapypalliative radiation therapyChemotherapy

Brief Summary

Currently, the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy and/or a symptomatic course of radiation therapy in doses less than ablative ones The aim of the study is to increase the effectiveness of treatment of patients with tumors of various localizations with oligometastases in the bones and internal organs with the help of stereotactic radiation therapy. The method of stereotactic radiation therapy will be applied in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy treatment T1-4, N0-3, M0-1, over 18 years of age at the start of treatment, compared with standard methods of palliative therapy in those same patient models.

Eligibility Criteria

Inclusion Criteria: 1. Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64). 2. 0-2 points on the WHO/ECOG scale of assessment of the general condition of the patient. 3. The absence of disease progression after the current line of chemotherapeutic treatment. 4. The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion. 5. The total number of distant metastases is no more than 5. 6. Life expectancy of more than 6 months for brain metastases (GPA-score) 7. The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design. 8. Making decisions on the inclusion of a patient in the study protocol based on the results of an interdisciplinary consultation consisting of an oncologist, a chemotherapist and a radiotherapist. 9. Signed informed consent Exclusion Criteria: 1. 3-4 points on the WHO/ECOG scale of assessment of the general condition of the patient 2

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