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Open Access 01-12-2022 | Radiotherapy | Study protocol

A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)

Authors: I. W. J. M. van Goor, L. A. Daamen, M. G. Besselink, A. M. E. Bruynzeel, O. R. Busch, G. A. Cirkel, B. Groot Koerkamp, N. Haj Mohammed, H. D. Heerkens, H. W. M. van Laarhoven, G. J. Meijer, J. Nuyttens, H. C. van Santvoort, G. van Tienhoven, H. M. Verkooijen, J. W. Wilmink, I. Q. Molenaar, M. P. W. Intven, for the Dutch Pancreatic Cancer Group

Published in: Trials | Issue 1/2022

Abstract

Background

Disease recurrence is the main cause of mortality after resection of pancreatic ductal adenocarcinoma (PDAC). In 20–30% of resected patients, isolated local PDAC recurrence occurs. Retrospective studies have suggested that stereotactic body radiation therapy (SBRT) might lead to improved local control in these patients, potentially having a beneficial effect on both survival and quality of life. The “nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy” (ARCADE) will investigate the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence compared to standard of care alone, regarding both survival and quality of life outcomes.

Methods

The ARCADE trial is nested within a prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the ‘Trials within Cohorts’ design. All PACAP participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies are eligible. Patients will be randomized for local therapy (5 fractions of 8 Gy SBRT) in addition to standard of care or standard of care alone. In total, 174 patients will be included. The main study endpoint is survival after recurrence. The most important secondary endpoint is quality of life.

Discussion

It is hypothesized that additional SBRT, compared to standard of care alone, improves survival and quality of life in patients with isolated local recurrence after PDAC resection.

Trial registration

ClinicalTrials.gov registration NCT04881487. Registered on May 11, 2021.

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Title: A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)
Authors: I. W. J. M. van Goor
L. A. Daamen
M. G. Besselink
A. M. E. Bruynzeel
O. R. Busch
G. A. Cirkel
B. Groot Koerkamp
N. Haj Mohammed
H. D. Heerkens
H. W. M. van Laarhoven
G. J. Meijer
J. Nuyttens
H. C. van Santvoort
G. van Tienhoven
H. M. Verkooijen
J. W. Wilmink
I. Q. Molenaar
M. P. W. Intven
for the Dutch Pancreatic Cancer Group
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Radiotherapy
Pancreatic Cancer
Pancreatic Cancer
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06829-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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