Evidence map›Paper›PMID 36221952›Full record

Trial reportCancer control : journal of the Moffitt Cancer Center

Induction Chemotherapy With FOLFIRINOX Followed by Chemoradiation With Gemcitabine in Patients With Borderline-Resectable Pancreatic Ductal Adenocarcinoma.

Ana Acuna-Villaorduna, Viswanathan Shankar, Michael Wysota, Amanda Jirgal, Rafi Kabarriti, Sarah Bellemare, Inessa Goldman, Andreas Kaubisch, Santiago Aparo, Sanjay Goel and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer control : journal of the Moffitt Cancer Center. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01897454 (A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 33% of its field
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.

NCT01897454 phase2terminatednot on this map

A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma

TypeinterventionalSponsorAlbert Einstein College of MedicineRan2012 to 2021Enrolled23ConditionsPancreatic Adenocarcinoma, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic CancerArmsFluorouracil, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy, Irinotecan Hydrochloride, Leucovorin Calcium
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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 at 2 institutions in 1 country.

Ana Acuna-VillaordunaDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Viswanathan ShankarDepartment of Epidemiology & Population Health, 2006Albert Einstein College of Medicine, Bronx, NY, USA.
Michael WysotaDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Amanda JirgalDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Rafi KabarritiDepartment of Radiation Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Sarah BellemareDepartment of Surgery, 2013Montefiore Medical Center, Bronx, NY, USA.
Inessa GoldmanDepartment of Radiology, 2013Montefiore Medical Center, Bronx, NY, USA.
Andreas KaubischDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Santiago AparoDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Sanjay GoelDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.
Jennifer ChuyDepartment of Medical Oncology, 2013Montefiore Medical Center, Bronx, NY, USA.ORCID 0000-0002-0279-7960
Albert Einstein College of Medicine · USMontefiore Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPerioperative therapy is standard for patients with borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC); however, an optimal neoadjuvant regimen is lacking. We assessed the efficacy of FOLFIRINOX chemotherapy followed by gemcitabine-based chemoradiation as preoperative therapy.

methodsPatients received 4 cycles of FOLFIRINOX, followed by 6-weekly gemcitabine with concomitant intensity-modulated radiation. The primary endpoint was the R0 resection rate. Secondary outcomes included resection rate, overall-response, overall survival (OS), progression-free survival (PFS), and tolerability. The trial was terminated early due to slow accrual. A Simon's optimal two-stage phase II trial single arm design was used. The primary hypothesis of treatment efficacy was tested using a multistage group sequential inference procedure. The secondary failure time analysis endpoints were assessed using the Kaplan-Meier procedure and the Cox regression model.

resultsA total of 22 patients enrolled in the study, 18 (81.8%) completed neoadjuvant treatment. The bias corrected R0 rate was 55.6% (90% CI: 33.3, 68.3;

conclusionAn R0 resection rate of 55.6% is favorable. Neoadjuvant FOLFIRINOX followed by concomitant Gemcitabine with radiation was well-tolerated. NCT01897454.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFluorouracilGemcitabineHumansInduction ChemotherapyIrinotecanLeucovorinNeoadjuvant TherapyOxaliplatinDeoxycytidineFluorouracilfolfirinoxGemcitabineIrinotecanLeucovorinOxaliplatinborderlineneoadjuvantpancreas

Identifiers

PMID36221952
PMCPMC9558866
OpenAlexW4304757164

What OpenQuestion holds

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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.