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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.
1. A patient with a previously verified diagnosis of a malignant neoplasm of one of the localizations (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64) who meets the inclusion criteria, after randomization by random numbers into the study group, is carried out:
Tumor localization / Description /Total focal dose, Gy/ Number of fractions /Single focal dose, Gy/ Irradiation mode:
Lung Tumors:
Bones TD24Gy in 3Fx with 8Gy every day
Brain Metastasis
Liver Radiation regimen selection based on tolerance of surrounding tissues and diligence to critical structures TD30-60Gy in 3-8Fx with 6-15Gy every day
Adrenal Glands TD60Gy in 8Fx with 7.5Gy every day
2. The expected duration of the patient's participation in clinical testing, a description of the sequence and duration of all periods of clinical testing, including the period of follow-up, if any;
Periods of clinical testing:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) arm | Experimental | The method of stereotactic radiation therapy in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment |
|
| Standart care arm | Active Comparator | Palliative radiation therapy or chemotherapy alone in patients with oligometastatic forms of tumors of various localizations after the current line of chemotherapy T1-4, N0-3, M0-1, aged over 18 years at the time of initiation of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic ablative radiation therapy | Radiation | stereotactic ablative radiation therapy in effective doses to each metastatic site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantin Gordon, PhD | Contact | +79105184148 | gordon@mrrc.obninsk.ru |
| Name | Affiliation | Role |
|---|---|---|
| Konstantin Gordon | A. Tsyb Medical Radiological Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A. Tsyb Medical Radiological Research Center | Recruiting | Obninsk | Kaluga Oblast | 249033 | Russia |
Data will be available upon request from the principal investigator for researchers, who meet the criteria for access to confidential data.
unlimited
informed consent for personal data non-disclosure
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| palliative radiation therapy | Radiation | palliative radiation therapy (8 Gy/1 Fx, 3 Gy x 10-15 Fx, 4,5 Gy x 5 Fx) |
|
| Chemotherapy | Drug | prescribed drug line |
|
| 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 |
| At approximately the end of month 1, 2, 3, 6, 12 (study completion) |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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