Stereotactic Radiation Therapy for Oligometastasis (1-5) in Various Tumor Sites in Comparison to Palliative Care of Oligometastatic Tumors.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
详细描述
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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:
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3-dimensional/4-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).
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The resulting images are added to the contouring program.
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Delineation of targets and risk organs is performed.
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The clinical volumes and margins for the errors are determined.
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Prescribing the total dose per target and dose limits for critical structures.
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Dosimetric planning of the course of external-beam radiation therapy is carried out.
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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-voltage/mega-voltage beam.
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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:
- of 3cm or less located in the parenchyma TD45Gy in 3Fx with 15Gy every day
- adjacent to the chest wall or less than 3 cm TD50Gy in 5Fx with 10Gy every day
- within 2 cm of the mediastinum or brachial plexus TD60Gy in 8Fx with 7.5Gy every day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant formation (ICD 10-11 codes С18, С19, С20, С34, С50, С61, С64).
- •0-2 points on the WHO/ECOG scale of assessment of the general condition of the patient.
- •The absence of disease progression after the current line of chemotherapeutic treatment.
- •The number of oligometastases is not more than 3 in one organ, in the presence of a multi-organ lesion.
- •The total number of distant metastases is no more than
- •Life expectancy of more than 6 months for brain metastases (GPA-score)
- •The possibility of SBRT for all distant metastases, in accordance with the criteria specified in the study design.
- •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.
- •Signed informed consent
排除标准
- •3-4 points on the WHO/ECOG scale of assessment of the general condition of the patient
- •The complete response of all foci to the chemotherapy.
- •Distant metastases only in the brain, without damage to bones and other organs.
- •Brain metastasis of more than 3 cm in one dimension, requiring surgical treatment.
- •Distant metastasis in the brain stem and spinal cord.
- •The size of at least one distant metastasis is more than 5 cm.
- •Previously performed radiation therapy on one of the metastatic foci.
- •Metastatic lesion of the pleura, membranes of the brain or peritoneum.
- •The impossibility of CTT for all distant metastases, in accordance with the criteria specified in the study design.
- •Invasion into great vessels (aorta, carotid arteries, pulmonary arteries, etc.), organs of the digestive tract (esophagus, stomach, intestines), skin.
- •Compression of the spinal cord by distant metastasis according to instrumental studies.
研究组 & 干预措施
Stereotactic Ablative Radiotherapy (SABR) arm
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
干预措施: stereotactic ablative radiation therapy (Radiation)
Standart care arm
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
干预措施: palliative radiation therapy (Radiation)
Standart care arm
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
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: At approximately end of year 1, 2,3 (study completion)
Time period before cancer progression after the treatment, assessed in months
Time before the current drug line change
时间窗: At approximately the end of years 1, 2, 3 (study completion)
Time period before the indication for drug therapy alteration after the treatment, assessed in months
次要结局
- Acute side effects(At approximately the end of months 1, 2, 3 (treatment completion))
- Late side effects(At approximately the end of years 1, 2, 3 (study completion))
- Overall survival(At approximately the end of years 1, 2, 3 (study completion))
- Local metastasis control(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))
研究者
Konstantin Gordon
Senior Researcher
National Medical Research Radiological Centre of the Ministry of Health of Russia