Evidence map›Paper›PMID 31494181›Full record

Trial reportInternational journal of radiation oncology, biology, physics2020

Phase 2 Trial of Neoadjuvant FOLFIRINOX and Intensity Modulated Radiation Therapy Concurrent With Fixed-Dose Rate-Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer.

Nguyen H Tran, Vaibhav Sahai, Kent A Griffith, Hari Nathan, Ravi Kaza, Kyle C Cuneo, Jiaqi Shi, Edward Kim, Christopher J Sonnenday, Clifford S Cho and 2 more

Open access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  9. Total neoadjuvant therapy for pancreatic adenocarcinoma increases probability for a complete pathologic response.European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology · 2022
    Article
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  18. Methodological Development of Combination Drug and Radiotherapy in Basic and Clinical Research.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Review
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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

12 authors at 2 institutions in 1 country.

Nguyen H TranUniversity of Michigan, Ann Arbor, Michigan. Electronic address: viclyssa@med.umich.edu.
Vaibhav SahaiUniversity of Michigan, Ann Arbor, Michigan.
Kent A GriffithUniversity of Michigan, Ann Arbor, Michigan.
Hari NathanUniversity of Michigan, Ann Arbor, Michigan.
Ravi KazaUniversity of Michigan, Ann Arbor, Michigan.
Kyle C CuneoUniversity of Michigan, Ann Arbor, Michigan.
Jiaqi ShiUniversity of Michigan, Ann Arbor, Michigan.
Edward KimWork completed at University of Michigan. Currently at University of California, Davis, California.
Christopher J SonnendayUniversity of Michigan, Ann Arbor, Michigan.
Clifford S ChoUniversity of Michigan, Ann Arbor, Michigan.
Theodore S LawrenceUniversity of Michigan, Ann Arbor, Michigan.
Mark M ZalupskiUniversity of Michigan, Ann Arbor, Michigan.
University of Michigan–Ann Arbor · USUniversity of California, Davis · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
Linking epigenetic regulation and TGF-β signaling in pancreatic cancerK08CA234222 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHI, JIAQI · 2018 to 2021
$744k
NCI NIH HHS K08 CA234222NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

purposePreoperative therapy in borderline resectable pancreatic cancer (BRPC) is intended to increase R0 resection rates. An optimal approach in BRPC is yet to be defined. METHODS AND MATERIALS: Patients with BRPC, confirmed adenocarcinoma, performance status ≤1, and adequate organ function enrolled in a single-institution, phase 2 trial. Patients received FOLFIRINOX × 6 cycles, then radiation therapy (50 Gy in 25 fractions) concurrent with fixed-dose rate gemcitabine (1 g/m

resultsTwenty-five patients with median age of 60 years (range, 47-77 years) enrolled from November 2011 through January 2017. Twenty-one (84%) completed FOLFIRINOX and 19 (76%) completed all protocol therapy. Treatment-related grade 3 to 4 toxicities included neutropenia (40%), nausea and vomiting (28%), diarrhea (16%), and fatigue (12%). Eighteen patients (72%) underwent laparotomy, 13 (52%) were resected (all R0). The median PFS and OS in 25 patients were 13.1 months (95% confidence interval [CI], 7.3-24.7) and 24.4 months (95% CI, 12.6-40.0), respectively. For resected patients, median PFS was 21.6 months (95% CI, 8.2-37.1) and OS was 37.1 months (95% CI, 15.4-not reached).

conclusionsNeoadjuvant therapy with FOLFIRINOX, followed by intensity modulated radiation therapy concurrent with fixed-dose-rate gemcitabine in BRPC is feasible and tolerated. Although the alternate hypothesis was not met, the OS of the resected cohort was favorable.

Indexed as

AdenocarcinomaAgedAntineoplastic Combined Chemotherapy ProtocolsCA-19-9 AntigenChemoradiotherapyDeoxycytidineDose Fractionation, RadiationFeasibility StudiesFemaleFluorouracilGemcitabineHumansIrinotecanLeucovorinMaleMiddle AgedCA-19-9 AntigenDeoxycytidineFluorouracilfolfirinoxGemcitabineIrinotecanLeucovorinOxaliplatin

Identifiers

PMID31494181
PMCPMC7245020
OpenAlexW2971438153

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.