Clinical trial NCT04075305: The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Official title: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: The Netherlands Cancer Institute
name: Sunnybrook Health Sciences Centre
name: M.D. Anderson Cancer Center
name: The Christie NHS Foundation Trust
name: Royal Marsden NHS Foundation Trust
name: Medical College of Wisconsin
name: Elekta Limited
name: Odense University Hospital
name: Radboud University Medical Center
name: Radiotherapiegroep
name: Jules Bordet Institute
name: University Hospital Tuebingen
name: Radiotherapeutic Institute Friesland
name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Austin Health
name: Princess Margaret Hospital, Canada
name: Università degli Studi di Brescia
First posted: 2019-08-30
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment and/or imaging on an MR-Linac machine are eligible for enrolment. Patients must meet eligibility criteria and provide informed consent to be enrolled.

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.

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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 3 months after MR-Linac treatment
measure: Progression-free Survival
timeFrame: 6 months after MR-Linac treatment
measure: Progression-free Survival
timeFrame: 24 months after MR-Linac treatment
measure: Survival
timeFrame: 3 months after MR-Linac treatment
measure: Survival
timeFrame: 6 months after MR-Linac treatment
measure: Survival
timeFrame: 24 months after MR-Linac treatment
measure: Disease-free Survival
timeFrame: 3 months after MR-Linac treatment
measure: Disease-free Survival
timeFrame: 6 months after MR-Linac treatment
measure: Disease-free Survival
timeFrame: 24 months after MR-Linac treatment
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 3 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 6 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 12 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 24 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 3 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 6 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 12 months after treatment.
measure: Patient reported Health related quality of life (HRQoL).
timeFrame: 24 months after treatment.
measure: Patient reported tumor specific quality of life (QoL).
timeFrame: 3 months after treatment.
measure: Patient reported tumor specific quality of life (QoL).
timeFrame: 6 months after treatment.
measure: Patient reported tumor specific quality of life (QoL).
timeFrame: 12 months after treatment.
measure: Patient reported tumor specific quality of life (QoL).
timeFrame: 24 months after treatment.
measure: Acute toxicity in common toxicity criteria for adverse events (CTCAE).
timeFrame: 3 months after treatment.
measure: Acute toxicity in common toxicity criteria for adverse events (CTCAE).
timeFrame: 6 months after treatment.
measure: Acute toxicity in common toxicity criteria for adverse events (CTCAE).
timeFrame: 12 months after treatment.
measure: Acute toxicity in common toxicity criteria for adverse events (CTCAE).
timeFrame: 24 months after treatment.
measure: Clinical tumor response.
timeFrame: 2 year follow up.
measure: Pathological tumor response.
timeFrame: 2 year follow up.
measure: Toxicity in common toxicity criteria for adverse events (CTCAE).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Melbourne
country: Australia
facility: Austin Health - Olivia Newton-John Cancer Wellness and Research Centre
city: Brussel
country: Belgium
facility: Insitut Jules Bordet
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre/Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Center
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Funen
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Brescia
country: Italy
facility: Università degli Studi di Brescia
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
city: Deventer
country: Netherlands
facility: Radiotherapiegroep
city: Leeuwarden
country: Netherlands
facility: Radiotherapeutisch Instituut Friesland (RIF)
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: London
country: United Kingdom
facility: The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
city: Manchester
country: United Kingdom
facility: The Christie National Health Service Foundation Trust
Study officials:
affiliation: Universitair Medical Centre Utrecht
name: Helena M Verkooijen, Prof, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan H, Stewart J, Ruschin M, Wang MH, Myrehaug S, Tseng CL, Detsky J, Husain Z, Chen H, Sahgal A, Soliman H. Inter-fraction dynamics during post-operative 5 fraction cavity hypofractionated stereotactic radiotherapy with a MR LINAC: a prospective serial imaging study. J Neurooncol. 2022 Feb;156(3):569-577. doi: 10.1007/s11060-021-03938-w. Epub 2022 Jan 3.
citation: de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Faivre-Finn C, Fuller CD, Goldwein J, Hafeez S, Hall E, Harrington KJ, van der Heide UA, Huddart RA, Intven MPW, Kirby AM, Lalondrelle S, McCann C, Minsky BD, Mook S, Nowee ME, Oelfke U, Orrling K, Sahgal A, Sarmiento JG, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Hall WA, Verkooijen HM. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.