Evidence map›Paper›PMID 31646981›Full record

ArticleBMC cancer2019

Nal-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary tract cancer - the NIFE trial (AIO-YMO HEP-0315) an open label, non-comparative, randomized, multicenter phase II study.

L Perkhofer, A W Berger, A K Beutel, E Gallmeier, S Angermeier, L Fischer von Weikersthal, T O Goetze, R Muche, T Seufferlein, T J Ettrich

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03044587 (Nal-IRI With 5-fluorouracil), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.9field-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.

NCT03044587 phase2completednot on this map

Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer - An Open Label, Non-comparative, Randomized, Multicenter Phase II Trial

TypeinterventionalSponsorAIO-Studien-gGmbHRan2018 to 2025Enrolled93ConditionsAdenocarcinoma Metastatic, Biliary Tract Cancer, Adenocarcinoma of the Biliary Tract, Adenocarinoma Locally AdvancedArmsArm NaI-IRI + 5-FU + Leucovorin (Arm A), Arm Cisplatin + Gemcitabine (Arm B)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Gemcitabine-based chemotherapy for advanced biliary tract carcinomas.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Progress toward improving outcomes in patients with cholangiocarcinoma.Current treatment options in gastroenterology · 2021
    Article
  8. Review
  9. Article
  10. Review
  11. 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

10 authors at 6 institutions in 1 country.

L PerkhoferDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany. lukas.perkhofer@uniklinik-ulm.de.
A W BergerDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
A K BeutelDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
E GallmeierDepartment of Gastroenterology and Endocrinology, University of Marburg, Baldingerstraße, 35043, Marburg, Germany.
S AngermeierInternal Medicine I, Klinikum Ludwigsburg, Posilipostraße 4, 71640, Ludwigsburg, Germany.
L Fischer von WeikersthalGesundheitszentrum St. Marien, Mariahilfbergweg 7, 92224, Amberg, Germany.
T O GoetzeInstitute of Clinical Cancer Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, Steinbacher Hohl 2-26, 60488, Frankfurt, Germany.
R MucheInstitute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, 89081, Ulm, Germany.
T SeufferleinDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
T J EttrichDepartment of Internal Medicine I, Ulm University, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Universität Ulm · DEKlinikum im Friedrichshain · DEKlinikum Ludwigsburg · DEKlinikum St. Marien Amberg · DEKrankenhaus Nordwest · DEPhilipps University of Marburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBiliary tract cancer (BTC) has a high mortality. Primary diagnosis is frequently delayed due to mostly unspecific symptoms, resulting in a high number of advanced cases at the time of diagnosis. Advanced BTCs are in principle chemotherapy sensitive as determined by improved disease control, survival and quality of life (QoL). However, median OS does not exceed 11.7 months with the current standard of care gemcitabine plus cisplatin. Thereby, novel drug formulations like nanoliposomal-irinotecan (nal-IRI) in combination with 5- fluorouracil (5-FU)/leucovorin may have the potential to improve therapeutic outcomes in this disease.

methodsNIFE is an interventional, prospective, randomized, controlled, open label, two-sided phase II study. Within the study, 2 × 46 patients with locally advanced, non-resectable or metastatic BTC are to be enrolled by two stage design of Simon. Data analysis will be done unconnected for both arms. Patients are allocated in two arms: Arm A (experimental intervention) nal-IRI mg/m DISCUSSION: The NIFE trial evaluates the potential of a nanoliposomal-irinotecan/5-FU/leucovorin combination in the first line therapy of advanced BTCs and additionally offers a unique chance for translational research.

trial registrationClinicaltrials.gov NCT03044587. Registration Date February 7th 2017.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCisplatinClinical Trials, Phase II as TopicDeoxycytidineDisease-Free SurvivalFemaleFluorouracilGemcitabineHumansIrinotecanLeucovorinMalePhospholipidsProgression-Free SurvivalQuality of LifeCisplatinDeoxycytidineFluorouracilGemcitabineIrinotecanLeucovorinliposomPhospholipidsBiliary tract cancerChemotherapyCholangiocarcinomaNanoliposomal-irinotecanPalliative treatment

Identifiers

PMID31646981
PMCPMC6813114
OpenAlexW2981705097

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.