Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. Palliative Care
NCT Number: NCT06556550
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Oligometastatic Disease
Interventions: RADIATION: stereotactic ablative radiation therapy|RADIATION: palliative radiation therapy|DRUG: Chemotherapy
Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-31
Completion Date: 2029-12-31
Locations: A. Tsyb Medical Radiological Research Center, Obninsk, Kaluga, 249033, Russian Federation

Summary:
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.

Primary Outcome Measures: Progression-free survival, Time period before cancer progression after the treatment, assessed in months, At approximately end of year 1, 2,3 (study completion)|Time before the current drug line change, Time period before the indication for drug therapy alteration after the treatment, assessed in months, At approximately the end of years 1, 2, 3 (study completion)
Secondary Outcome Measures: Acute side effects, Local changes of tissues after the treatment, assessed in accordance to CTCAE v5.0, At approximately the end of months 1, 2, 3 (treatment completion)|Late side effects, Local changes of tissues after the treatment, assessed in accordance to CTCAE v 5.0, At approximately the end of years 1, 2, 3 (study completion)|Overall survival, Time period before patient death after the treatment, assessed in years, At approximately the end of years 1, 2, 3 (study completion)|Local metastasis control, Time period before irradiated targets relapse, assessed in years/months, At approximately the end of years 1, 2, 3 (study completion)|Quality of life Assessed with the Functional Assessment via EQ-5D (EuroQolGroup Scale) and The Numerical Rating Pain Scale, 1. Functional Assessment via EQ-5D (EuroQolGroup Scale). The scale will be applied before treatment, and after the treatment at month 1, 2, 3, 6, 12 The system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (a 1-digit number that expresses the level). The EQ visual-analogue records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. It will be used as a quantitative measure of health outcome that reflects the patient's own judgement.
2. in case of painful targets The Numerical Rating Pain Scale will be applied before and after the treatment at month 1, 2, 3, 6, 12 . Score 0 (no pain) to 10 (maximal pain), At approximately the end of month 1, 2, 3, 6, 12 (study completion)