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

Launched by NATIONAL MEDICAL RESEARCH RADIOLOGICAL CENTRE OF THE MINISTRY OF HEALTH OF RUSSIA · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called stereotactic radiation therapy for patients with oligometastatic disease, which means they have a limited number of cancer spread (metastases) in one or more organs. The goal is to see if this targeted radiation therapy can be more effective than the usual palliative care methods, like chemotherapy or general radiation therapy, in helping patients manage their cancer and improve their quality of life.

To be eligible for this study, participants must be adults over 18 years old with confirmed cancer in specific areas, such as the lungs or bones, and should not have more than five metastases total, with no more than three in any one organ. They should also have a good overall health status and not show any signs of the disease getting worse after their last treatment. If you or a loved one meets these criteria, joining this trial may offer an opportunity for potentially more effective treatment while being closely monitored by a team of healthcare professionals.

Gender

ALL

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. The complete response of all foci to the chemotherapy.
• • 3. Distant metastases only in the brain, without damage to bones and other organs.
• • 4. Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
• • 5. Distant metastasis in the brain stem and spinal cord.
• • 6. The size of at least one distant metastasis is more than 5 cm.
• • 7. Previously performed radiation therapy on one of the metastatic foci.
• • 8. Metastatic lesion of the pleura, membranes of the brain or peritoneum.
• • 9. The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.
• • 10. Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.
• • 11. Compression of the spinal cord by distant metastasis according to instrumental studies.