Evidence map›Paper›PMID 34980020›Full record

ArticleBMC cancer2022

PIONEER-Panc: a platform trial for phase II randomized investigations of new and emerging therapies for localized pancreatic cancer.

Julia E Douglas, Suyu Liu, Junsheng Ma, Robert A Wolff, Shubham Pant, Anirban Maitra, Eric P Tamm, Priya Bhosale, Matthew H G Katz, Gauri R Varadhachary and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04481204 (PIONEER-Panc), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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.

NCT04481204 phase2withdrawnnot on this mapstarted 2023, after this paper: background citation

PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2023 to 2026Enrolled0ConditionsBorderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal AdenocarcinomaArmsCisplatin, Fluorouracil, Gemcitabine, Irinotecan, Leucovorin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Locally Advanced Pancreas Cancer, Is There a Role for Surgery?The Surgical clinics of North America · 2024
    Review
  5. Review
  6. Neoadjuvant therapy for pancreatic cancer.Nature reviews. Clinical oncology · 2023
    Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Julia E DouglasDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1220 Holcombe Boulevard, MS97, Houston, TX, 77030, USA.
Suyu LiuDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Junsheng MaDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Robert A WolffDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shubham PantDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Anirban MaitraSheikh Ahmed Center for Pancreatic Cancer Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Eric P TammDepartment of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Priya BhosaleDepartment of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Matthew H G KatzDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gauri R VaradhacharyDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Eugene J KoayDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1220 Holcombe Boulevard, MS97, Houston, TX, 77030, USA. EKoay@mdanderson.org.ORCID http://orcid.org/0000-0001-7675-3461

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Clinical Validation Center for Early Detection of Pancreatic CancerU01CA200468 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI ANIRBAN MAITRA · 2016 to 2026
$11.0M
TRANS-NETWORK PROJECTSU54CA143837 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI FERRARI, MAURO · 2009 to 2014
$10.8M
Transport Oncophysics CoreU54CA210181 · NCI · METHODIST HOSPITAL RESEARCH INSTITUTE · PI CHANG, JENNY C-N · 2016 to 2020
$9.3M
Circulating Biomarkers and Imaging for Early Detection of Pancreatic CancerU01CA214263 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI EUGENE J KOAY, Subrata Sen · 2018 to 2026
$7.2M
Imaging and Molecular Correlates of Progression in Cystic Neoplasms of the PancreasU01CA196403 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MAITRA, ANIRBAN · 2015 to 2020
$5.8M
Targeting Focal Adhesion Kinase to Improve RT-inducted Tumor ImmunityR01CA248917 · NCI · WASHINGTON UNIVERSITY · PI DENARDO, DAVID G, KIM, HYUN · 2020 to 2024
$2.5M
Translational Applications in an Animal Model of Pancreatic Cystic Neoplasm and CancerR01CA218004 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MAITRA, ANIRBAN · 2018 to 2021
$2.4M
Optimization and Evaluation of Anatomical Models of Liver Radiation ResponseR01CA221971 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BROCK, KRISTY · 2018 to 2022
$1.8M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA218004NCI NIH HHS R01 CA221971NCI NIH HHS R01 CA248917NCI NIH HHS U01 CA196403NCI NIH HHS U01 CA200468NCI NIH HHS U01 CA214263NCI NIH HHS U54 CA143837NCI NIH HHS U54 CA210181
6 · The paper itself

Abstract

backgroundPersonalized and effective treatments for pancreatic ductal adenocarcinoma (PDAC) continue to remain elusive. Novel clinical trial designs that enable continual and rapid evaluation of novel therapeutics are needed. Here, we describe a platform clinical trial to address this unmet need.

methodsThis is a phase II study using a Bayesian platform design to evaluate multiple experimental arms against a control arm in patients with PDAC. We first separate patients into three clinical stage groups of localized PDAC (resectable, borderline resectable, and locally advanced disease), and further divide each stage group based on treatment history (treatment naïve or previously treated). The clinical stage and treatment history therefore define 6 different cohorts, and each cohort has one control arm but may have one or more experimental arms running simultaneously. Within each cohort, adaptive randomization rules are applied and patients will be randomized to either an experimental arm or the control arm accordingly. The experimental arm(s) of each cohort are only compared to the applicable cohort specific control arm. Experimental arms may be added independently to one or more cohorts during the study. Multiple correlative studies for tissue, blood, and imaging are also incorporated. DISCUSSION: To date, PDAC has been treated as a single disease, despite knowledge that there is substantial heterogeneity in disease presentation and biology. It is recognized that the current approach of single arm phase II trials and traditional phase III randomized studies are not well-suited for more personalized treatment strategies in PDAC. The PIONEER Panc platform clinical trial is designed to overcome these challenges and help advance our treatment strategies for this deadly disease.

trial registrationThis study is approved by the Institutional Review Board (IRB) of MD Anderson Cancer Center, IRB-approved protocol 2020-0075. The PIONEER trial is registered at the US National Institutes of Health (ClinicalTrials.gov) NCT04481204 .

Indexed as

Antineoplastic ProtocolsCarcinoma, Pancreatic DuctalClinical Trials, Phase II as TopicPancreatic NeoplasmsRandomized Controlled Trials as TopicAdaptive Clinical Trials as TopicAdultBayes TheoremFemaleHumansMaleNeoadjuvant TherapyTreatment OutcomeBorderline resectableFOLFIRINOXGemcitabine/nab-paclitaxelLocally advancedPancreatic cancerPancreatic ductal adenocarcinoma (PDAC)Phase IIPIONEERRandomized platform trialResectable

Identifiers

PMID34980020
PMCPMC8722115

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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.