Breast Cancer Clinical Trial
— MOMENTUMOfficial title:
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.
Status | Recruiting |
Enrollment | 8000 |
Est. completion date | May 1, 2025 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Austin Health - Olivia Newton-John Cancer Wellness and Research Centre | Melbourne | |
Belgium | Insitut Jules Bordet | Brussel | |
Canada | Sunnybrook Health Sciences Centre/Odette Cancer Centre | Toronto | Ontario |
Canada | University Health Network - Princess Margaret Cancer Center | Toronto | |
Denmark | Odense Universitetshospital | Odense | Funen |
Germany | Universitätsklinikum Tübingen | Tübingen | |
Italy | Università degli Studi di Brescia | Brescia | |
Italy | IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | |
Netherlands | Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital | Amsterdam | |
Netherlands | Radiotherapiegroep | Deventer | |
Netherlands | Radiotherapeutisch Instituut Friesland (RIF) | Leeuwarden | |
Netherlands | Radboud UMC | Nijmegen | |
Netherlands | University Medical Center Utrecht | Utrecht | |
United Kingdom | The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre | London | |
United Kingdom | The Christie National Health Service Foundation Trust | Manchester | |
United States | Md Anderson Cancer Center | Houston | Texas |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Allegheny Health Network | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Austin Health, Elekta Limited, IRCCS Sacro Cuore Don Calabria di Negrar, Jules Bordet Institute, M.D. Anderson Cancer Center, Medical College of Wisconsin, Odense University Hospital, Princess Margaret Hospital, Canada, Radboud University Medical Center, Radiotherapeutic Institute Friesland, Radiotherapiegroep, Royal Marsden NHS Foundation Trust, Sunnybrook Health Sciences Centre, The Christie NHS Foundation Trust, The Netherlands Cancer Institute, Università degli Studi di Brescia, University Hospital Tuebingen |
United States, Australia, Belgium, Canada, Denmark, Germany, Italy, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Toxicity in common toxicity criteria for adverse events (CTCAE). | Disease-specific toxicity is obtained from the hospital information system. | 2 years |
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