The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
- Conditions
- OncologyGynecologic CancerBrain CancerProstate TumorProstate NeoplasmLung TumorEsophageal TumorEsophageal NeoplasmHead and Neck CancerBladder Cancer
- Interventions
- Radiation: Radiation therapy
- Registration Number
- NCT04075305
- Lead Sponsor
- UMC Utrecht
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pancreatic cancer Radiation therapy - Rectal cancer Radiation therapy - Breast Cancer Radiation therapy - Gynecological cancer Radiation therapy - Lung cancer Radiation therapy - Bladder cancer Radiation therapy - Oligometastases Radiation therapy - Brain cancer Radiation therapy - Esophageal cancer Radiation therapy - Head and Neck Cancer Radiation therapy - Liver cancer Radiation therapy - Prostate cancer Radiation therapy - Other types of cancer Radiation therapy -
- Primary Outcome Measures
Name Time Method 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'.
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.
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). 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 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 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. 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 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). 2 years Disease-specific toxicity is obtained from the hospital information system.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
The Christie National Health Service Foundation Trust
🇬🇧Manchester, United Kingdom
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
🇬🇧London, United Kingdom
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre
🇦🇺Melbourne, Australia
Sunnybrook Health Sciences Centre/Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
University Health Network - Princess Margaret Cancer Center
🇨🇦Toronto, Canada
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Radiotherapiegroep
🇳🇱Deventer, Netherlands
Odense Universitetshospital
🇩🇰Odense, Funen, Denmark
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Radboud UMC
🇳🇱Nijmegen, Netherlands
Insitut Jules Bordet
🇧🇪Brussel, Belgium
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Radiotherapeutisch Instituut Friesland (RIF)
🇳🇱Leeuwarden, Netherlands
Università degli Studi di Brescia
🇮🇹Brescia, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands