Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04075305




Registration number
NCT04075305
Ethics application status
Date submitted
22/03/2019
Date registered
30/08/2019
Date last updated
28/09/2023

Titles & IDs
Public title
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Scientific title
The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Secondary ID [1] 0 0
NL66650.041.18
Universal Trial Number (UTN)
Trial acronym
MOMENTUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncology 0 0
Breast Cancer 0 0
Prostate Cancer 0 0
Gynecologic Cancer 0 0
Brain Tumor 0 0
Brain Cancer 0 0
Gynecologic Tumor 0 0
Prostate Tumor 0 0
Prostate Neoplasm 0 0
Breast Tumor 0 0
Radiation Toxicity 0 0
Quality of Life 0 0
Rectal Cancer 0 0
Rectal Tumor 0 0
Rectal Neoplasms 0 0
Lung Cancer 0 0
Lung Tumor 0 0
Lung Neoplasm 0 0
Esophageal Cancer 0 0
Esophagus Cancer 0 0
Esophageal Tumor 0 0
Esophageal Neoplasm 0 0
Esophagus Tumor 0 0
Esophagus Neoplasm 0 0
Pancreatic Cancer 0 0
Pancreatic Tumor 0 0
Pancreatic Neoplasms 0 0
Head and Neck Cancer 0 0
Head and Neck Neoplasms 0 0
Head and Neck Tumor 0 0
Tumor 0 0
Neoplasms 0 0
Bladder Cancer 0 0
Bladder Neoplasm 0 0
Liver Cancer 0 0
Liver Neoplasms 0 0
Liver Metastases 0 0
Oligometastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Radiation therapy

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 -


Treatment: Other: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
3 months after MR-Linac treatment
Primary outcome [2] 0 0
Progression-free Survival
Timepoint [2] 0 0
6 months after MR-Linac treatment
Primary outcome [3] 0 0
Progression-free Survival
Timepoint [3] 0 0
24 months after MR-Linac treatment
Primary outcome [4] 0 0
Survival
Timepoint [4] 0 0
3 months after MR-Linac treatment
Primary outcome [5] 0 0
Survival
Timepoint [5] 0 0
6 months after MR-Linac treatment
Primary outcome [6] 0 0
Survival
Timepoint [6] 0 0
24 months after MR-Linac treatment
Primary outcome [7] 0 0
Disease-free Survival
Timepoint [7] 0 0
3 months after MR-Linac treatment
Primary outcome [8] 0 0
Disease-free Survival
Timepoint [8] 0 0
6 months after MR-Linac treatment
Primary outcome [9] 0 0
Disease-free Survival
Timepoint [9] 0 0
24 months after MR-Linac treatment
Primary outcome [10] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [10] 0 0
3 months after treatment.
Primary outcome [11] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [11] 0 0
6 months after treatment.
Primary outcome [12] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [12] 0 0
12 months after treatment.
Primary outcome [13] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [13] 0 0
24 months after treatment.
Primary outcome [14] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [14] 0 0
3 months after treatment.
Primary outcome [15] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [15] 0 0
6 months after treatment.
Primary outcome [16] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [16] 0 0
12 months after treatment.
Primary outcome [17] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [17] 0 0
24 months after treatment.
Primary outcome [18] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [18] 0 0
3 months after treatment.
Primary outcome [19] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [19] 0 0
6 months after treatment.
Primary outcome [20] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [20] 0 0
12 months after treatment.
Primary outcome [21] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [21] 0 0
24 months after treatment.
Primary outcome [22] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [22] 0 0
3 months after treatment.
Primary outcome [23] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [23] 0 0
6 months after treatment.
Primary outcome [24] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [24] 0 0
12 months after treatment.
Primary outcome [25] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [25] 0 0
24 months after treatment.
Primary outcome [26] 0 0
Clinical tumor response.
Timepoint [26] 0 0
2 year follow up.
Primary outcome [27] 0 0
Pathological tumor response.
Timepoint [27] 0 0
2 year follow up.
Primary outcome [28] 0 0
Toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [28] 0 0
2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussel
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
Denmark
State/province [7] 0 0
Funen
Country [8] 0 0
Germany
State/province [8] 0 0
Tübingen
Country [9] 0 0
Italy
State/province [9] 0 0
Brescia
Country [10] 0 0
Italy
State/province [10] 0 0
Negrar
Country [11] 0 0
Netherlands
State/province [11] 0 0
Amsterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Deventer
Country [13] 0 0
Netherlands
State/province [13] 0 0
Leeuwarden
Country [14] 0 0
Netherlands
State/province [14] 0 0
Nijmegen
Country [15] 0 0
Netherlands
State/province [15] 0 0
Utrecht
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Netherlands Cancer Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Health Sciences Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
M.D. Anderson Cancer Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Christie NHS Foundation Trust
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal Marsden NHS Foundation Trust
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Medical College of Wisconsin
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Elekta Limited
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Odense University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Radboud University Medical Center
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Radiotherapiegroep
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Jules Bordet Institute
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
University Hospital Tuebingen
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Radiotherapeutic Institute Friesland
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
IRCCS Sacro Cuore Don Calabria di Negrar
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Government body
Name [16] 0 0
Austin Health
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Princess Margaret Hospital, Canada
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Università degli Studi di Brescia
Address [18] 0 0
Country [18] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helena M Verkooijen, Prof, Dr
Address 0 0
Universitair Medical Centre Utrecht
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tessa Leer
Address 0 0
Country 0 0
Phone 0 0
T +31 (0)88 75 63707
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04075305