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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06272162
Other study ID # NL85622.041.24
Secondary ID 1503023U-0725
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date January 2030

Study information

Verified date February 2024
Source UMC Utrecht
Contact Lois Daamen, MD, PhD
Phone + 316 51223276
Email L.a.daamen-3@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).


Description:

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Study Design


Related Conditions & MeSH terms

  • Locally Advanced Pancreatic Adenocarcinoma

Intervention

Radiation:
MR guided radiotherapy
5 fractions of 10 Gray MRgRT in addition to standard of care

Locations

Country Name City State
Netherlands Amsterdam University Medical Center, VUmc Amsterdam Noord-Holland
Netherlands Catharina Hospital Eindhoven Noord- Brabant
Netherlands Radboud University Medical Center Nijmegen
Netherlands University Medical Center Utrecht Utrecht

Sponsors (6)

Lead Sponsor Collaborator
UMC Utrecht Amsterdam UMC, location VUmc, Catharina Ziekenhuis Eindhoven, Centre for Human Drug Research, Netherlands, Dutch Pancreatic Cancer Group (DPCG), Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary HRQoL deterioration-free survival HRQoL deterioration-free survival is defined as the Time Until Definitive Deterioration (TUDD) including death from any cause, calculated from the time of randomization. HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary Score. Through study completion, an average of 18 months
Secondary Overall survival The time interval between LAPC diagnosis and either death from any cause or last follow-up From the date of LAPC diagnosis untill either death from any cause or last follow-up, whichever came first, assessed up to 18 months
Secondary Patient reported Quality of Life EORTC QLQ-PAN26 Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-PAN26 At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Secondary Patient reported Quality of Life EORTC QLQ-C30 Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-C30 At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Secondary Patient reported Quality of Life EQ5D-5L Part of the Patient Reported Outcome Measures (PROMs) using EQ5D-5L At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Secondary The need of subsequent treatments To assess continuation of systemic therapy and/or administration of subsequent treatments (e.g., surgery, second-line systemic treatment, experimental treatment in clinical studies etc.), recommendations from multidisciplinary team meetings, reasons for refraining from recommended therapy, and reasons for discontinuation of therapy (i.e., start of best supportive care) Through study completion, an average of 18 months
Secondary Treatment response assessed on CT-imaging (graded according to RECIST guidelines) To assess tumor response on imaging according to RECIST criteria in patients who received imaging procedures during follow-up (no part of the trial follow-up) with available imaging during 18 months follow-up
Secondary CA 19.9 response To assess serum CA 19-9 response in patients in whom serum CA 19-9 is measured (no part of the trial follow-up) Through study completion, an average of 18 months
Secondary Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch To assess the feasibility of the Trial@home monitoring via the Withings Steel HR smartwatch for home monitoring of pancreatic cancer patients.
Compliance Withings Steel HR smartwatch (wear-time): amount of time (hours) in a day that the participant wears the smartwatch. This is calculated by the amount of time the device registers a heart rate. Patients wearing the device for >50% of the observation period will be considered as feasible.
Through study completion, an average of 18 months
Secondary Trial@home monitoring related outcome: feasibility Body+ scale To assess the feasibility of the Trial@home monitoring via the Body+ scale for home monitoring of pancreatic cancer patients.
Compliance rates Body+ scale: compliance with weekly weight measurements is calculated by the number of completed weight measurements divided by the total amount of weeks in the observation period. A compliance rate of at least 75% will be considered as feasible.
Through study completion, an average of 18 months
Secondary Trial@home monitoring related outcome: feasibility Whitings Sleep To assess the feasibility of the Trial@home monitoring via the Whitings Sleep for home monitoring of pancreatic cancer patients.
Compliance Whitings Sleep: compliance with daily sleep monitoring is calculated by the number of nights sleep is measured. A compliance rate of at least 75% nights per week will be considered as feasible.
Through study completion, an average of 18 months
Secondary Trial@home monitoring related outcome: feasibility ePRO application To assess the feasibility of the Trial@home monitoring via the ePRO application for home monitoring of pancreatic cancer patients.
Compliance questionnaires through the ePROapplication: A compliance rate of at least 75% from the scheduled assessments will be considered as feasible.
Through study completion, an average of 18 months
Secondary Trial@home monitoring related outcome: digital biomarkers To exploratively generate digital biomarkers and quantify the correlation between data obtained from the Trial@home platform (Withings Steel HR smartwatch, a Withings Body+ Scale, a Withings Sleep, ePRO) and clinical endpoints (e.g., unplanned hospitalizations, early signs of adverse events, clinical deterioration, performance status, quality of life) Through study completion, an average of 18 months
Secondary Intervention arm related outcome toxicity To assess acute (3 months) RT-related toxicity measured from the start of MRgRT, according to CTCAE v527 Through study completion, an average of 18 months
Secondary Intervention arm related outcome, completion of therapy To assess completion of therapy Through study completion, an average of 18 months
Secondary Intervention arm related outcome diffusion weighted images To assess correlation of diffusion weighted images at each treatment fraction and the possible correlation with outcomes for patients treated on a 1.5T MR-Linac Through study completion, an average of 18 months
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