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

Breast Cancer Clinical Trial

— MOMENTUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075305
• Other study ID #: NL66650.041.18
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: May 1, 2025

Study information

• Verified date: September 2023
• Source: UMC Utrecht
• Contact: Tessa Leer
• Phone: T +31 (0)88 75 63707
• Email: T.Leer[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Neoplasm
• Brain Cancer
• Brain Neoplasms
• Brain Tumor
• Breast Cancer
• Breast Neoplasms
• Breast Tumor
• Esophageal Cancer
• Esophageal Neoplasm
• Esophageal Neoplasms
• Esophageal Tumor
• Esophagus Cancer
• Esophagus Neoplasm
• Esophagus Tumor
• Genital Neoplasms, Female
• Gynecologic Cancer
• Gynecologic Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Head and Neck Tumor
• Liver Cancer
• Liver Metastases
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms
• Lung Tumor
• Neoplasms
• Oligometastases
• Oncology
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatic Tumor
• Prostate Cancer
• Prostate Neoplasm
• Prostate Tumor
• Prostatic Neoplasms
• Quality of Life
• Radiation Toxicity
• Rectal Cancer
• Rectal Neoplasms
• Rectal Tumor
• Tumor
• Urinary Bladder Neoplasms

Intervention

Radiation:
• Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac

Locations

Country	Name	City	State
Australia	Austin Health - Olivia Newton-John Cancer Wellness and Research Centre	Melbourne
Belgium	Insitut Jules Bordet	Brussel
Canada	Sunnybrook Health Sciences Centre/Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network - Princess Margaret Cancer Center	Toronto
Denmark	Odense Universitetshospital	Odense	Funen
Germany	Universitätsklinikum Tübingen	Tübingen
Italy	Università degli Studi di Brescia	Brescia
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Negrar
Netherlands	Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Radiotherapiegroep	Deventer
Netherlands	Radiotherapeutisch Instituut Friesland (RIF)	Leeuwarden
Netherlands	Radboud UMC	Nijmegen
Netherlands	University Medical Center Utrecht	Utrecht
United Kingdom	The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre	London
United Kingdom	The Christie National Health Service Foundation Trust	Manchester
United States	Md Anderson Cancer Center	Houston	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (19)

Lead Sponsor

Collaborator

UMC Utrecht

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Austin Health, Elekta Limited, IRCCS Sacro Cuore Don Calabria di Negrar, Jules Bordet Institute, M.D. Anderson Cancer Center, Medical College of Wisconsin, Odense University Hospital, Princess Margaret Hospital, Canada, Radboud University Medical Center, Radiotherapeutic Institute Friesland, Radiotherapiegroep, Royal Marsden NHS Foundation Trust, Sunnybrook Health Sciences Centre, The Christie NHS Foundation Trust, The Netherlands Cancer Institute, Università degli Studi di Brescia, University Hospital Tuebingen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Toxicity in common toxicity criteria for adverse events (CTCAE).	Disease-specific toxicity is obtained from the hospital information system.	2 years