The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 8,000
- 试验地点
- 18
- 主要终点
- Clinical tumor response.
研究概览
简要总结
The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.
详细描述
Rationale: Radiation therapy has become indispensable in cancer treatment. However, it is associated with severe side effects. Innovation in radiation therapy has resulted in the development of MR-guided radiation therapy (MRGRT) which allows high precision radiotherapy under real time MR visualization. High precision MRGRT has the potential of dose escalation and margin reduction and may potentially lead to higher cure rates and less toxicity. MRGRT can be delivered by the MRI guided Linear Accelerator (MR-Linac) which integrates a state-of-the-art linear accelerator, 1.5T diagnostic quality MRI and an online adaptive workflow.
Objective
The Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) aims to accelerate the technical and clinical development of Anatomic and Biologic MRGRT and facilitate the evidence-based introduction of the MR-Linac into clinical practice. In MOMENTUM, technical and clinical data are gathered in order to optimize software, evaluate treatment outcomes, toxicities and progression free, disease free, and overall survival per disease site, and create a repository of anatomical and biological MR sequences to develop new features.
Study design: A multi-institutional, international observational cohort study. Study population: Cancer patients ≥ 18 years receiving treatment and/or imaging on an MR-Linac machine are eligible for enrollment.
Main study parameters/endpoints: MOMENTUM will collect technical and clinical patient data. The technical patient data is defined as data generated by (the use of) the MR-Linac and will include data collection during scans performed during routine care as well as research MRIs. Clinical data will be categorized into six classes: demographic, disease characteristics, treatment classifiers, toxicity outcomes, cancer control outcomes and PROs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;
- •Patient provides written, informed consent;
- •Patient is 18 years old or older.
排除标准
- •MRI exclusion criteria, including
- •MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.
研究组 & 干预措施
Gynecological cancer
干预措施: Radiation therapy (Radiation)
Rectal cancer
干预措施: Radiation therapy (Radiation)
Brain cancer
干预措施: Radiation therapy (Radiation)
Lung cancer
干预措施: Radiation therapy (Radiation)
Esophageal cancer
干预措施: Radiation therapy (Radiation)
Breast Cancer
干预措施: Radiation therapy (Radiation)
Head and Neck Cancer
干预措施: Radiation therapy (Radiation)
Pancreatic cancer
干预措施: Radiation therapy (Radiation)
Bladder cancer
干预措施: Radiation therapy (Radiation)
Oligometastases
干预措施: Radiation therapy (Radiation)
Liver cancer
干预措施: Radiation therapy (Radiation)
Other types of cancer
干预措施: Radiation therapy (Radiation)
Prostate cancer
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Clinical tumor response.
时间窗: 2 year follow up.
Clinical tumor response in participating patients is obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.
Patient reported tumor specific quality of life (QoL).
时间窗: 24 months after treatment.
Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
时间窗: 24 months after treatment.
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Progression-free Survival
时间窗: 24 months after MR-Linac treatment
Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Survival
时间窗: 24 months after MR-Linac treatment
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Pathological tumor response.
时间窗: 2 year follow up.
Pathological tumor response in participating patients who undergo surgery are obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.
Disease-free Survival
时间窗: 24 months after MR-Linac treatment
Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Toxicity in common toxicity criteria for adverse events (CTCAE).
时间窗: 2 years
Disease-specific toxicity is obtained from the hospital information system.
Patient reported Health related quality of life (HRQoL).
时间窗: 24 months after treatment.
Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Progression-free Survival
时间窗: 3 months after MR-Linac treatment
Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Progression-free Survival
时间窗: 6 months after MR-Linac treatment
Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Survival
时间窗: 3 months after MR-Linac treatment
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Survival
时间窗: 6 months after MR-Linac treatment
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Disease-free Survival
时间窗: 3 months after MR-Linac treatment
Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Disease-free Survival
时间窗: 6 months after MR-Linac treatment
Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Patient reported Health related quality of life (HRQoL).
时间窗: 3 months after treatment.
Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported Health related quality of life (HRQoL).
时间窗: 6 months after treatment.
Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive, and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported Health related quality of life (HRQoL).
时间窗: 12 months after treatment.
Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported tumor specific quality of life (QoL).
时间窗: 3 months after treatment.
Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported tumor specific quality of life (QoL).
时间窗: 6 months after treatment.
Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported tumor specific quality of life (QoL).
时间窗: 12 months after treatment.
Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
时间窗: 3 months after treatment.
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
时间窗: 6 months after treatment.
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
时间窗: 12 months after treatment.
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
次要结局
未报告次要终点