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JOURNAL ONKOLOGIE – STUDIE
MOMENTUM

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

Rekrutierend

NCT-Nummer:
NCT04075305

Studienbeginn:
Februar 2019

Letztes Update:
28.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms, Head and Neck Neoplasms, Urinary Bladder Neoplasms, Esophageal Neoplasms, Brain Neoplasms, Liver Neoplasms, Lung Neoplasms, Breast Neoplasms, Genital Neoplasms, Female

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
UMC Utrecht

Collaborator:
The Netherlands Cancer Institute, Sunnybrook Health Sciences Centre, M.D. Anderson Cancer Center, The Christie NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Medical College of Wisconsin, Elekta Limited, Odense University Hospital, Radboud University M

Studienleiter

Helena M Verkooijen, Prof, Dr
Principal Investigator
Universitair Medical Centre Utrecht

Kontakt

Studienlocations
(3 von 18)

University Medical Center Utrecht
3508GA Utrecht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Helena M Verkooijen, Prof, Dr
E-Mail: h.m.verkooijen@umcutrecht.nl

Tessa Leer
E-Mail: T.Leer@umcutrecht.nl» Ansprechpartner anzeigen
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Shaista Hafeez» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Progression-free Survival (Time Frame - 3 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.

2. Progression-free Survival (Time Frame - 6 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.

3. Progression-free Survival (Time Frame - 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.

4. Survival (Time Frame - 3 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.

5. Survival (Time Frame - 6 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.

6. Survival (Time Frame - 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.

7. Disease-free Survival (Time Frame - 3 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.

8. Disease-free Survival (Time Frame - 6 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.

9. Disease-free Survival (Time Frame - 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.

10. Patient reported Health related quality of life (HRQoL). (Time Frame - 3 months after treatment.):
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.

11. Patient reported Health related quality of life (HRQoL). (Time Frame - 6 months after treatment.):
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. Patient reported Health related quality of life (HRQoL). (Time Frame - 12 months after treatment.):
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.

13. Patient reported Health related quality of life (HRQoL). (Time Frame - 24 months after treatment.):
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.

14. Patient reported Health related quality of life (HRQoL). (Time Frame - 3 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'.

15. Patient reported Health related quality of life (HRQoL). (Time Frame - 6 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'.

16. Patient reported Health related quality of life (HRQoL). (Time Frame - 12 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'.

17. Patient reported Health related quality of life (HRQoL). (Time Frame - 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'.

18. Patient reported tumor specific quality of life (QoL). (Time Frame - 3 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.

19. Patient reported tumor specific quality of life (QoL). (Time Frame - 6 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.

20. Patient reported tumor specific quality of life (QoL). (Time Frame - 12 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.

21. Patient reported tumor specific quality of life (QoL). (Time Frame - 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.

22. Acute toxicity in common toxicity criteria for adverse events (CTCAE). (Time Frame - 3 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.

23. Acute toxicity in common toxicity criteria for adverse events (CTCAE). (Time Frame - 6 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.

24. Acute toxicity in common toxicity criteria for adverse events (CTCAE). (Time Frame - 12 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.

25. Acute toxicity in common toxicity criteria for adverse events (CTCAE). (Time Frame - 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.

26. Clinical tumor response. (Time Frame - 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.

27. Pathological tumor response. (Time Frame - 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.

28. Toxicity in common toxicity criteria for adverse events (CTCAE). (Time Frame - 2 years):
Disease-specific toxicity is obtained from the hospital information system.

Studien-Arme

  • Brain cancer
  • Lung cancer
  • Esophageal cancer
  • Breast Cancer
  • Head and Neck Cancer
  • Pancreatic cancer
  • Gynecological cancer
  • Rectal cancer
  • Prostate cancer
  • Bladder cancer
  • Oligometastases
  • Liver cancer
  • Other types of cancer

Geprüfte Regime

  • Radiation therapy:
    Radiation therapy on the CE marked and FDA approved MR-Linac

Quelle: ClinicalTrials.gov


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