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

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 tumour control and quality of life.

Trial Description

Primary Outcome:

• Progression-free Survival
• Progression-free Survival
• Progression-free Survival
• Survival
• Survival
• Survival
• Disease-free Survival
• Disease-free Survival
• Disease-free Survival
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported Health related quality of life (HRQoL).
• Patient reported tumour specific quality of life (QoL).
• Patient reported tumour specific quality of life (QoL).
• Patient reported tumour specific quality of life (QoL).
• Patient reported tumour specific quality of life (QoL).
• Acute toxicity in common toxicity criteria for adverse events (CTCAE).
• Acute toxicity in common toxicity criteria for adverse events (CTCAE).
• Acute toxicity in common toxicity criteria for adverse events (CTCAE).
• Acute toxicity in common toxicity criteria for adverse events (CTCAE).
• Clinical tumour response.
• Pathological tumour response.
• Toxicity in common toxicity criteria for adverse events (CTCAE).

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 radiation therapy 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.

View this trial on ClinicalTrials.gov