Evidence map›Paper›PMID 36307892›Full record

Trial reportTrials2022

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

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 and 9 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04881487 (A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04881487 narecruitingnot on this map

A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

TypeinterventionalSponsorUMC UtrechtRan2021 to 2028Enrolled174ConditionsRecurrent Pancreatic Ductal AdenocarcinomaArmsAdditional stereotactic body radiation therapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

I W J M van GoorDepartment of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands. i.w.j.vangoor-5@umcutrecht.nl.ORCID http://orcid.org/0000-0003-3770-9841
L A DaamenDepartment of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
M G BesselinkDepartment of Surgery, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
A M E BruynzeelCancer Center Amsterdam, Amsterdam, the Netherlands.
O R BuschDepartment of Surgery, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
G A CirkelDepartment of Medical Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
B Groot KoerkampDepartment of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.
N Haj MohammedDepartment of Medical Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
H D HeerkensDepartment of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
H W M van LaarhovenCancer Center Amsterdam, Amsterdam, the Netherlands.
G J MeijerDepartment of Radiation Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
J NuyttensDepartment of Radiation Oncology, Erasmus Medical Center, Rotterdam, the Netherlands.
H C van SantvoortDepartment of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
G van TienhovenCancer Center Amsterdam, Amsterdam, the Netherlands.
H M VerkooijenDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.
J W WilminkCancer Center Amsterdam, Amsterdam, the Netherlands.
I Q MolenaarDepartment of Surgery, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands.
M P W IntvenDepartment of Radiation Oncology, Regional Academic Cancer Center Utrecht, Utrecht, the Netherlands. m.intven@umcutrecht.nl.
Dutch Pancreatic Cancer Group

Funding

KWF Kankerbestrijding 12568 / 2019-2
6 · The paper itself

Abstract

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

Indexed as

Carcinoma, Pancreatic DuctalPancreatic NeoplasmsRadiosurgeryHumansNeoplasm Recurrence, LocalPituitary Adenylate Cyclase-Activating PolypeptideProspective StudiesQuality of LifeRetrospective StudiesPituitary Adenylate Cyclase-Activating PolypeptideDisease recurrenceImage-guided radiotherapyIsolated local recurrencePancreatic cancerPancreatic ductal adenocarcinomaPDACSABRSBRTStereotactic body radiation therapy

Identifiers

PMID36307892
PMCPMC9617359

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.