The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Conditions
-----------------
Tumor, Esophagus Tumor, Oncology, Breast Cancer, Prostate Cancer, Gynecologic Cancer, Brain Tumor, Brain Cancer, Gynecologic Tumor, Prostate Tumor, Prostate Neoplasm, Breast Tumor, Radiation Toxicity, Quality of Life, Rectal Cancer, Rectal Tumor, Rectal Neoplasms, Lung Cancer, Lung Tumor, Lung Neoplasm, Esophageal Cancer, Esophagus Cancer, Esophageal Tumor, Esophageal Neoplasm, Esophagus Neoplasm, Pancreatic Cancer, Pancreatic Tumor, Pancreatic Neoplasms, Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Tumor, Neoplasms, Bladder Cancer, Bladder Neoplasm, Liver Cancer, Liver Neoplasms, Liver Metastases, Oligometastases

Intervention / Treatment
-----------------
* Radiation: Radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brain cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Lung cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Esophageal cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Breast Cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Head and Neck Cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Pancreatic cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Gynecological cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Rectal cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Prostate cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Bladder cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Oligometastases<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Liver cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|
| Other types of cancer<br> | Radiation: Radiation therapy<br>* Radiation therapy on the CE marked and FDA approved MR-Linac<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | 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. | 3 months after MR-Linac treatment | 
| Progression-free Survival | 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. | 6 months after MR-Linac treatment | 
| Progression-free Survival | 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. | 24 months after MR-Linac treatment | 
| Survival | Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices. | 3 months after MR-Linac treatment | 
| Survival | Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices. | 6 months after MR-Linac treatment | 
| Survival | Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices. | 24 months after MR-Linac treatment | 
| Disease-free Survival | 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. | 3 months after MR-Linac treatment | 
| Disease-free Survival | 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. | 6 months after MR-Linac treatment | 
| Disease-free Survival | 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. | 24 months after MR-Linac treatment | 
| Patient reported Health related quality of life (HRQoL). | 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. | 3 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | 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. | 6 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | 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. | 12 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | 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. | 24 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'. | 3 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'. | 6 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'. | 12 months after treatment. | 
| Patient reported Health related quality of life (HRQoL). | Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'. | 24 months after treatment. | 
| Patient reported tumor specific quality of life (QoL). | 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. | 3 months after treatment. | 
| Patient reported tumor specific quality of life (QoL). | 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. | 6 months after treatment. | 
| Patient reported tumor specific quality of life (QoL). | 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. | 12 months after treatment. | 
| Patient reported tumor specific quality of life (QoL). | 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. | 24 months after treatment. | 
| Acute toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. | 3 months after treatment. | 
| Acute toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. | 6 months after treatment. | 
| Acute toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. | 12 months after treatment. | 
| Acute toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary. | 24 months after treatment. | 
| Clinical tumor response. | 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. | 2 year follow up. | 
| Pathological tumor response. | 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. | 2 year follow up. | 
| Toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. | 2 years |