Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556550
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Stereotactic Radiotherapy for Oligometastasis 1-5 in Various Tumor Sites vs Palliative Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stereotactic Radiation Therapy for Oligometastasis 1-5 in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently the usual standard of palliative treatment used in patients with diagnosed oligometastatic cancer in accordance with the local clinical recommendations is chemotherapy andor 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
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
Detailed Description:
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
1 3-dimensional4-dimensional computed tomography for simulation using specialized fixation devices the choice of the method of computed tomography and fixing devices will be carried out depending on the location of the metastasis
2 The resulting images are added to the contouring program
3 Delineation of targets and risk organs is performed
4 The clinical volumes and margins for the errors are determined
5 Prescribing the total dose per target and dose limits for critical structures
6 Dosimetric planning of the course of external-beam radiation therapy is carried out
7 Irradiation sessions are carried out on a linear accelerator with a multi-leaf collimator with the presence of a function for visual control of the target using cone tomography with a kilo-voltagemega-voltage beam
8 When the target is localized in the lungs liver and adrenal glands in order to reduce the radiation load on the surrounding healthy tissues and achieve the necessary control over the position of metastasis irradiation is carried out with a deep breath hold or at certain phases of respiration
Tumor localization Description Total focal dose Gy Number of fractions Single focal dose Gy Irradiation mode
Lung Tumors
1 of 3cm or less located in the parenchyma TD45Gy in 3Fx with 15Gy every day
2 adjacent to the chest wall or less than 3 cm TD50Gy in 5Fx with 10Gy every day
3 within 2 cm of the mediastinum or brachial plexus TD60Gy in 8Fx with 75Gy every day
Bones TD24Gy in 3Fx with 8Gy every day
Brain Metastasis
1 volume from 05 to 5 cm3 TD20-22Gy in 1Fx at a time
2 volume of metastasis is from 5 to 10 cm3 TD16-18Gy or TD18-20Gy in 1 Fx at a time
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 75Gy every day
2 The expected duration of the patients 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
pre-hospital includes a comprehensive examination of the patient before treatment
inpatient includes pre-radiation training for up to 3 working days remote radiation therapy from one to eight working days
follow-up - after 3 6 9 12 18 24 months
collection and processing of the received data
1 3-dimensional4-dimensional computed tomography for simulation using specialized fixation devices the choice of the method of computed tomography and fixing devices will be carried out depending on the location of the metastasis
2 The resulting images are added to the contouring program
3 Delineation of targets and risk organs is performed
4 The clinical volumes and margins for the errors are determined
5 Prescribing the total dose per target and dose limits for critical structures
6 Dosimetric planning of the course of external-beam radiation therapy is carried out
7 Irradiation sessions are carried out on a linear accelerator with a multi-leaf collimator with the presence of a function for visual control of the target using cone tomography with a kilo-voltagemega-voltage beam
8 When the target is localized in the lungs liver and adrenal glands in order to reduce the radiation load on the surrounding healthy tissues and achieve the necessary control over the position of metastasis irradiation is carried out with a deep breath hold or at certain phases of respiration
Tumor localization Description Total focal dose Gy Number of fractions Single focal dose Gy Irradiation mode
Lung Tumors
1 of 3cm or less located in the parenchyma TD45Gy in 3Fx with 15Gy every day
2 adjacent to the chest wall or less than 3 cm TD50Gy in 5Fx with 10Gy every day
3 within 2 cm of the mediastinum or brachial plexus TD60Gy in 8Fx with 75Gy every day
Bones TD24Gy in 3Fx with 8Gy every day
Brain Metastasis
1 volume from 05 to 5 cm3 TD20-22Gy in 1Fx at a time
2 volume of metastasis is from 5 to 10 cm3 TD16-18Gy or TD18-20Gy in 1 Fx at a time
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 75Gy every day
2 The expected duration of the patients 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
pre-hospital includes a comprehensive examination of the patient before treatment
inpatient includes pre-radiation training for up to 3 working days remote radiation therapy from one to eight working days
follow-up - after 3 6 9 12 18 24 months
collection and processing of the received data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None