Evidence map›Paper›PMID 34772353›Full record

ArticleBMC cancer2021

Ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic pancreatic neuroendocrine tumors (RamuNET): study protocol for a multicenter single-arm trial.

Sebastian Krug, Thomas Kegel, Thomas M Gress, Anja Rinke, Leonidas Apostolidis, Henning Jann, Alexander König, Dieter Hörsch, Jörg Schrader, Thomas J Ettrich and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 46% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

13 authors at 8 institutions in 1 country.

Sebastian KrugDepartment of Internal Medicine I, Martin-Luther University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Germany.
Thomas KegelDepartment of Internal Medicine IV, Martin-Luther University Halle/Wittenberg, Halle, Germany.
Thomas M GressDepartment of Gastroenterology, Endocrinology and Metabolism, Philipps-University Marburg, Marburg, Germany.
Anja RinkeDepartment of Gastroenterology, Endocrinology and Metabolism, Philipps-University Marburg, Marburg, Germany.
Leonidas ApostolidisDepartment of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.
Henning JannDepartment of Gastroenterology and Hepatology, Charité University Hospital, Berlin, Germany.
Alexander KönigDepartment of Gastroenterology and gastrointestinal Oncology, Georg-August University, Göttingen, Germany.
Dieter HörschDepartment of Gastroenterology/Endocrinology, Center for Neuroendocrine Tumors Bad Berka, Bad Berka, Germany.
Jörg SchraderDepartment of Medicine - Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Thomas J EttrichDepartment of Internal Medicine I, University of Ulm, Ulm, Germany.
Michael RichterCoordination Centre for Clinical Trials, Faculty of Medicine, Martin-Luther University Halle/Wittenberg, Halle, Germany.
Jörg SteighardtCoordination Centre for Clinical Trials, Faculty of Medicine, Martin-Luther University Halle/Wittenberg, Halle, Germany.
Patrick MichlDepartment of Internal Medicine I, Martin-Luther University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Germany. patrick.michl@uk-halle.de.
Martin Luther University Halle-Wittenberg · DEPhilipps University of Marburg · DECharité - Universitätsmedizin Berlin · DEHeidelberg University · DEUniversität Hamburg · DEUniversität Ulm · DEUniversity of Göttingen · DEZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCytotoxic chemotherapy combinations and targeted agents represent established treatment concepts in advanced pancreatic neuroendocrine tumors (PNETs). However, response rates, side effects and outcome data strongly vary among these therapeutic approaches. Head-to-head comparisons between chemo- and molecular therapies are missing and secondary resistances frequently occur. The RamuNET trial aims to identify the effectiveness of dual treatment with DTIC and ramucirumab in progressive advanced PNET patients.

methodsThe RamuNET study is an investigator-initiated multicenter prospective single-arm trial to evaluate the efficacy of ramucirumab in combination with dacarbazine (DTIC) over a period of at least 6 months. Patients with progressive well-differentiated and metastatic pancreatic neuroendocrine tumors are eligible. The study aims to include 45 patients over a period of 24 months with a minimum follow-up of 24 months. The primary endpoint is disease control after 6 months. Secondary endpoints include progression-free survival, biochemical response, overall survival, quality of life and toxicity. Based on the hypothesis that 80% of the patients can achieve a disease control after 6 months, the sample size calculation follows an exact binomial single-stage design. H0: p < =p DISCUSSION: This study investigates a new therapeutic approach using the combination of cytotoxic and targeted antiangiogenic therapy in advanced PNET. If positive, this trial will be the basis for a randomized two-arm study to investigate the combination of ramucirumab and DTIC against other established therapies in PNET.

trial registrationEudraCT: 2017-001207-68 . Date of registration: 2018.01.03.

Indexed as

Angiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDacarbazineNeuroendocrine TumorsPancreatic NeoplasmsAdultAgedHumansMiddle AgedMulticenter Studies as TopicPilot ProjectsProspective StudiesRamucirumabTime FactorsAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDacarbazineRamucirumabVascular Endothelial Growth Factor Receptor-2ChemotherapyDTICNeuroendocrinePanNETPNETRamucirumab

Identifiers

PMID34772353
PMCPMC8588662
OpenAlexW3212782699

What OpenQuestion holds

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LicenceCC BY
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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.