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

Recruiting now · Phase 2/Phase 3

Conditions studied: Oligometastatic Disease

In brief

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.

Key facts

Study ID

NCT06556550

Run by

National Medical Research Radiological Centre of the Ministry of Health of Russia

People needed

100

Starts

2024-05-31

Expected to finish

2029-12-31

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• A. Tsyb Medical Radiological Research Center — Obninsk, Kaluga Oblast, Russia (enrolling)

Full record on ClinicalTrials.gov

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