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

Titre officiel

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

Sommaire:

L’étude MOMENTUM (évaluation de multiples résultats de la radiothérapie guidée par le système IRM-Linac) est un registre international multi-institutionnel qui vise à faciliter la mise en œuvre de la technologie fondée sur des données probantes IRM-Linac, ainsi que des futures avancées techniques du système IRM-Linac, dans le but ultime d’améliorer la survie et la qualité de vie des patients, et la maîtrise des tumeurs locales et régionales.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov