Status:
RECRUITING
Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
Lead Sponsor:
National Medical Research Radiological Centre of the Ministry of Health of Russia
Conditions:
Oligometastatic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
Detailed Description
1\. A patient with a previously verified diagnosis of a malignant neoplasm of one of the localizations (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64) who meets the inclusion criteria, after rando...
Eligibility Criteria
Inclusion
- Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).
- 0-2 points on the WHO/ECOG scale of assessment of the general condition of the patient.
- The absence of disease progression after the current line of chemotherapeutic treatment.
- The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.
- The total number of distant metastases is no more than 5.
- Life expectancy of more than 6 months for brain metastases (GPA-score)
- The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design.
- 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.
- Signed informed consent
Exclusion
- 3-4 points on the WHO/ECOG scale of assessment of the general condition of the patient
- The complete response of all foci to the chemotherapy.
- Distant metastases only in the brain, without damage to bones and other organs.
- Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
- Distant metastasis in the brain stem and spinal cord.
- The size of at least one distant metastasis is more than 5 cm.
- Previously performed radiation therapy on one of the metastatic foci.
- Metastatic lesion of the pleura, membranes of the brain or peritoneum.
- The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.
- Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.
- Compression of the spinal cord by distant metastasis according to instrumental studies.
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06556550
Start Date
May 31 2024
End Date
December 31 2029
Last Update
August 16 2024
Active Locations (1)
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1
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, Russia, 249033