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New treatment option for Oligometastatic Disease
Official title Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
ClinicalTrials.gov ID: NCT06556550
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for oligometastatic disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Obninsk, Kaluga Oblast, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Obninsk, Kaluga Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.