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2019-02-01
2024-02-01
2025-05-01
8000
NCT04075305
UMC Utrecht
UMC Utrecht
OBSERVATIONAL
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-03-22 | N/A | 2023-09-25 |
2019-08-28 | N/A | 2023-09-28 |
2019-08-30 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Brain cancer | RADIATION: Radiation therapy
|
| : Lung cancer | RADIATION: Radiation therapy
|
| : Esophageal cancer | RADIATION: Radiation therapy
|
| : Breast Cancer | RADIATION: Radiation therapy
|
| : Head and Neck Cancer | RADIATION: Radiation therapy
|
| : Pancreatic cancer | RADIATION: Radiation therapy
|
| : Gynecological cancer | RADIATION: Radiation therapy
|
| : Rectal cancer | RADIATION: Radiation therapy
|
| : Prostate cancer | RADIATION: Radiation therapy
|
| : Bladder cancer | RADIATION: Radiation therapy
|
| : Oligometastases | RADIATION: Radiation therapy
|
| : Liver cancer | RADIATION: Radiation therapy
|
| : Other types of cancer | RADIATION: Radiation therapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Tessa Leer Phone Number: T +31 (0)88 75 63707 Email: T.Leer@umcutrecht.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
