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

Trials

Study Protocol

J. W. Wilmink¹  H. W. M. van Laarhoven¹  G. van Tienhoven²  A. M. E. Bruynzeel³  G. A. Cirkel⁴  N. Haj Mohammed⁴  J. Nuyttens⁵  H. D. Heerkens⁶  G. J. Meijer⁷  M. P. W. Intven⁷  O. R. Busch⁸  M. G. Besselink⁸  B. Groot Koerkamp⁹  H. C. van Santvoort^1,10  I. Q. Molenaar^1,10  I. W. J. M. van Goor^1,11  L. A. Daamen^1,12  H. M. Verkooijen^1,13 

[1] Cancer Center Amsterdam, Amsterdam, the Netherlands;Department of Medical Oncology, Amsterdam University Medical Center, location University of Amsterdam, Amsterdam, the Netherlands;Cancer Center Amsterdam, Amsterdam, the Netherlands;Department of Radiation Oncology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands;Cancer Center Amsterdam, Amsterdam, the Netherlands;Department of Radiation Oncology, Amsterdam University Medical Center, location Vrije Universiteit, Amsterdam, the Netherlands;Department of Medical Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Department of Radiation Oncology, Erasmus Medical Center, Rotterdam, the Netherlands;Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands;Department of Radiation Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Department of Surgery, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands;Cancer Center Amsterdam, Amsterdam, the Netherlands;Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands;Department of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Department of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Department of Radiation Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Department of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands;Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, the Netherlands;Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, the Netherlands;

关键词: Pancreatic cancer;    Pancreatic ductal adenocarcinoma;    PDAC;    Disease recurrence;    Isolated local recurrence;    Stereotactic body radiation therapy;    SBRT;    SABR;    Image-guided radiotherapy;   

DOI  :  10.1186/s13063-022-06829-1

 received in 2022-08-09, accepted in 2022-10-06,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundDisease 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.MethodsThe 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.DiscussionIt 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 registrationClinicalTrials.gov registration NCT04881487. Registered on May 11, 2021.

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

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