Stereotactic radiotherapy for patients with oligometastatic cancer

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

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.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Obninsk, Kaluga Oblast)
• Trial ID: NCT06556550 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Obninsk, Kaluga Oblast

• 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

Conditions Oligometastatic Disease; stereotactic radiation therapy; stereotactic body radiation therapy; stereotactic ablative radiation therapy