NCT06556550 Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
| NCT ID | NCT06556550 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National Medical Research Radiological Centre of the Ministry of Health of Russia |
| Condition | Oligometastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-05-31 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Contact & Investigator
Konstantin Gordon
PRINCIPAL INVESTIGATOR
A. Tsyb Medical Radiological Research Center
Frequently Asked Questions
Who can join the NCT06556550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oligometastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06556550 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06556550 currently recruiting?
Yes, NCT06556550 is actively recruiting participants. Contact the research team at gordon@mrrc.obninsk.ru for enrollment information.
Where is the NCT06556550 trial being conducted?
This trial is being conducted at Obninsk, Russia.
Who is sponsoring the NCT06556550 clinical trial?
NCT06556550 is sponsored by National Medical Research Radiological Centre of the Ministry of Health of Russia. The principal investigator is Konstantin Gordon at A. Tsyb Medical Radiological Research Center. The trial plans to enroll 100 participants.