Actively Recruiting
Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
Led by National Medical Research Radiological Centre of the Ministry of Health of Russia · Updated on 2024-08-16
100
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed malignant tumor of specified types (ICD 10-11 codes 2118, 2119, 2120, 2134, 2150, 2161, 2164)
- WHO/ECOG performance status of 0 to 2
- No disease progression after current chemotherapy
- No more than 3 oligometastases in any one organ if multiple organs are affected
- Total distant metastases count no more than 5
- Life expectancy over 6 months for brain metastases (based on GPA score)
- Ability to receive stereotactic body radiation therapy for all distant metastases per study criteria
- Inclusion decision made by interdisciplinary consultation of oncologist, chemotherapist, and radiotherapist
- Signed informed consent
You will not qualify if you...
- WHO/ECOG performance status of 3 or 4
- Complete response of all tumor sites to chemotherapy
- Distant metastases only in the brain without bone or other organ involvement
- Brain metastasis larger than 3 cm requiring surgery
- Metastases in brain stem or spinal cord
- Any distant metastasis larger than 5 cm
- Previous radiation therapy to any metastatic site
- Metastatic involvement of pleura, brain membranes, or peritoneum
- Inability to receive stereotactic body radiation therapy for all metastases per study criteria
- Invasion into major blood vessels, digestive organs, or skin
- Compression of the spinal cord by metastasis based on imaging studies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, Russia, 249033
Actively Recruiting
Research Team
K
Konstantin Gordon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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