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

Sponsor

UMC Utrecht (Other)

Overall Status

Recruiting

CT.gov ID

NCT04075305

Collaborator

The Netherlands Cancer Institute (Other), Sunnybrook Health Sciences Centre (Other), M.D. Anderson Cancer Center (Other), The Christie NHS Foundation Trust (Other), Royal Marsden NHS Foundation Trust (Other), Medical College of Wisconsin (Other), Elekta Limited (Industry), Odense University Hospital (Other)

6,000

Enrollment

Locations

Anticipated Duration (Months)

750

Patients Per Site

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Tumor Esophagus Neoplasm Pancreatic Cancer Pancreatic Tumor Pancreatic Neoplasms Head and Neck Cancer Head and Neck Neoplasms Head and Neck Tumor Tumor Neoplasms Bladder Cancer Bladder Neoplasm Liver Cancer Liver Neoplasms Liver Metastases Oligometastases	Radiation: Radiation therapy

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Progression-free Survival [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 [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.
Progression-free Survival [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 [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 [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.
Survival [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.
Disease-free Survival [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 [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.
Disease-free Survival [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.
Patient reported Health related quality of life (HRQoL). [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). [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). [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 Health related quality of life (HRQoL). [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.
Patient reported Health related quality of life (HRQoL). [3 months after treatment.]
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'.
Patient reported Health related quality of life (HRQoL). [6 months after treatment.]
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'.
Patient reported Health related quality of life (HRQoL). [12 months after treatment.]
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'.
Patient reported Health related quality of life (HRQoL). [24 months after treatment.]
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'.
Patient reported tumor specific quality of life (QoL). [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). [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). [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.
Patient reported tumor specific quality of life (QoL). [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). [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). [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). [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.
Acute toxicity in common toxicity criteria for adverse events (CTCAE). [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.
Clinical tumor response. [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.
Pathological tumor response. [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.
Toxicity in common toxicity criteria for adverse events (CTCAE). [2 years]
Disease-specific toxicity is obtained from the hospital information system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Md Anderson Cancer Center	Houston	Texas	United States	77030
2	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
3	Sunnybrook Health Sciences Centre/Odette Cancer Centre	Toronto	Ontario	Canada
4	Odense Universitetshospital	Odense	Funen	Denmark	5000
5	Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital	Amsterdam		Netherlands
6	University Medical Center Utrecht	Utrecht		Netherlands	3508GA
7	The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre	London		United Kingdom
8	The Christie National Health Service Foundation Trust	Manchester		United Kingdom