Evidence map›Paper›PMID 30327875›Full record

Trial reportJournal of gastroenterology2019

Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial.

Renate Schmelz, Stephan Miehlke, Christian Thiede, Stefan Brueckner, Monic Dawel, Matthias Kuhn, Agnes Ruskoné-Formestraux, Manfred Stolte, Christina Jentsch, Jochen Hampe and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00154440 (Treatment of Low-Grade Gastric Non-Hodgkin's Lymphoma of Mucosa-Associated Lymphoid Tissue), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00154440 phase3unknown statusnot on this map

Treatment of Low-Grade Gastric Non-Hodgkin's Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)

TypeinterventionalSponsorTechnische Universität DresdenRan2001 to 2013Enrolled200ConditionsLymphoma, Lymphoma, Non-HodgkinArmsproton pump inhibitor, clarithromycin, amoxicillin, metronidazole, radiation therapy
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Effectiveness ofWorld journal of gastroenterology · 2023
    Pooled it
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  7. [Characteristics of Gastric Mucosa-associated Lymphoid Tissue Lymphoma in Korea].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
    Review
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  11. Review
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  14. Radiotherapy for gastric mucosa-associated lymphoid tissue lymphoma.World journal of gastrointestinal oncology · 2021
    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

11 authors at 4 institutions in 2 countries.

Renate SchmelzMedical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany. renate.schmelz@uniklinikum-dresden.de.ORCID http://orcid.org/0000-0002-9012-2153
Stephan MiehlkeCenter for Digestive Diseases, Cooperation of Internal Medicine, Hamburg, Germany.
Christian ThiedeMedical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.
Stefan BruecknerMedical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.
Monic DawelDepartment of Radiation Oncology, Faculty of Medicine, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.
Matthias KuhnInstitute for Medical Informatics and Biometry, Technical University, Dresden, Germany.
Agnes Ruskoné-FormestrauxService de Gastroentérologie, St Antoine Hospital, Paris, France.
Manfred StolteInstitute for Pathology, Hospital Kulmbach, Kulmbach, Germany.
Christina JentschDepartment of Radiation Oncology, Faculty of Medicine, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.
Jochen HampeMedical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.
Andrea MorgnerUniversity Hospital Hamburg-Eppendorf, Center for Oncology and University Cancer Center Hamburg (UCCH), Hamburg, Germany.
University Hospital Carl Gustav Carus · DEInstitut für Medizinische Informatik, Biometrie und Epidemiologie · DESorbonne Université · FRUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Helicobacter pylori (H. pylori) positive stage I gastric low-grade MALT lymphoma, eradication is the accepted first-line therapy. The role of eradication therapy in lymphoma > stage IE is still unclear. However, about 20% of patients show persistent lymphoma following successful eradication or primary H. pylori-negative lymphoma. A prospective study for salvage radiation therapy with standard 36 Gy in comparison to a reduced dose of 25.2 Gy is still missing.

methodsA prospective, multicentre study investigated the efficacy of eradication in H. pylori-positive gastric low-grade MALT lymphoma stages IE and II1E (HELYX I). Refractory lymphoma or H. pylori-negative patients were treated in a prospective, randomised, multicentre, phase II study to receive either 25.2 Gy or 36 Gy radiotherapy (HELYX II).

results102 patients (3 drop outs) were included in HELYX I: 75/99 (75.8%) showed complete remission after a median of 2.8 months. 18 (18.2%) had partial remission (PR) and 6 (6.0%) no change (NC). 29 patients (7 drop outs) were randomized in HELYX II (7 primarily H. pylori-negative, 15 patients from HELYX I with refractory disease after eradication). All patients achieved stable CR irrespective of radiation dose. Both presence of the t(11,18) translocation (OR 9.0, p = 0.01) and monoclonality of the tumour cells (OR 6.3, p = 0.006) were predictors for persistant lymphoma after eradication therapy.

conclusionsMost H. pylori-positive low grade gastric MALT lymphoma stage IE and II1E respond with stable CR after eradication therapy. In patients with refractory disease or H. pylori negative low grade gastric MALT lymphoma a dosage-reduced radiation therapy with 25.2 Gy is an effective standard dose in stage IE and II1E.

trial registrationClinicalTrials.gov: NCT00154440.

Indexed as

Helicobacter pyloriAdultAgedAged, 80 and overFemaleHelicobacter InfectionsHumansLymphoma, B-Cell, Marginal ZoneMaleMiddle AgedNeoplasm GradingNeoplasm StagingProspective StudiesRadiotherapy DosageSalvage TherapyStomach NeoplasmsEradicationGastric low-grade MALT lymphomaRadiotherapyTranslocation (11;18)

Identifiers

PMID30327875
OpenAlexW2897595762

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.