Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 and up

Stereotactic radiotherapy for patients with oligometastatic cancer

Official title: Stereotactic Radiation Therapy for Oligometastasis (1-5) in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors.

Run by National Medical Research Radiological Centre of the Ministry of Health of Russia · NCT06556550 · Data updated 2026-11-12

This study tests whether a special type of targeted radiation therapy can help people with a few metastatic tumors feel better compared to standard care after chemotherapy.

More Oligometastatic Disease trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Obninsk, Kaluga Oblast)
StatusRecruiting
StartedMay 31, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2029
Registry record updatedAugust 16, 2024
Trial IDNCT06556550 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with histologically confirmed oligometastatic cancer and a good performance status.

Probably not a fit

Patients with poor performance status or those with extensive metastatic disease beyond the study criteria may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of stereotactic radiation therapy in patients with oligometastatic cancer, which is characterized by 1 to 5 metastatic tumors in various locations. Patients who have undergone a line of chemotherapy will be randomized to receive either stereotactic radiation therapy or standard palliative care. The methodology includes advanced imaging techniques for precise targeting of tumors and minimizing radiation exposure to healthy tissues. The goal is to improve treatment outcomes compared to conventional palliative approaches.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance survival and quality of life for patients with oligometastatic disease.

How similar studies have gone: Previous studies have shown promising results with stereotactic radiation therapy in similar patient populations, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • A. Tsyb Medical Radiological Research Center
    Obninsk, Kaluga Oblast, Russia
    Recruiting

Study contacts

  • Principal investigator: Konstantin Gordon — A. Tsyb Medical Radiological Research Center
  • Study coordinator: Konstantin Gordon, PhD
  • Email: gordon@mrrc.obninsk.ru
  • Phone: +79105184148

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.