Evidence map›Paper›PMID 30021548›Full record

Trial reportBMC cancer2018

A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients (GrantPax).

Johannes Betge, Jing Chi-Kern, Nadine Schulte, Sebastian Belle, Tobias Gutting, Elke Burgermeister, Ralf Jesenofsky, Martin Maenz, Ulrich Wedding, Matthias P Ebert and 1 more

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

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02812992 (A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.0field-weighted citation impact, top 10% 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.

NCT02812992 phase4completednot on this map

A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

TypeinterventionalSponsorAIO-Studien-gGmbHRan2016 to 2021Enrolled32ConditionsAdenocarcinoma PancreasArmsNab-paclitaxel, Gemcitabine, Best Supportive Care
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Systemic oncological treatments in patients with advanced pancreatic cancer: a scoping review and evidence map.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  5. Observational
  6. Review
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
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 3 institutions in 1 country.

Johannes BetgeDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.ORCID http://orcid.org/0000-0001-9549-1866
Jing Chi-KernDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Nadine SchulteDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Sebastian BelleDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Tobias GuttingDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Elke BurgermeisterDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Ralf JesenofskyDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Martin MaenzAIO-Studien gGmbH, Berlin, Germany.
Ulrich WeddingDepartment of Medicine II, University Hospital Jena, Jena, Germany.
Matthias P EbertDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. matthias.ebert@medma.uni-heidelberg.de.
Nicolai HaertelDepartment of Medicine II, Medical Faculty Mannheim, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. nicolai.haertel@medma.uni-heidelberg.de.
Heidelberg University · DEAIO Studien gGmbH · DEJena University Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the group of elderly patients (≥70 years) with metastatic pancreatic ductal adenocarcinoma (mPDAC), it is not known who benefits from intensive 1st line nab-paclitaxel/gemcitabine (nab-p/gem) combination chemotherapy or who would rather suffer from increased toxicity. We aim to determine whether treatment individualization by comprehensive geriatric assessments (CGAs) improves functional outcome of the patients. METHODS/

designGrantPax is a multicenter, open label phase 4 interventional trial. We use a CGA to stratify elderly patients into three parallel treatment groups (n = 45 per arm): 1) GOGO (nab-p/gem), 2) SLOWGO (gem mono) or 3) FRAIL (best supportive care). After the 1st cycle of chemotherapy (or 4 weeks in FRAIL group) another CGA and safety assessment is performed. CGA-stratified patients may not decline in their CGA performance in response to the first cycle of chemotherapy (primary objective), measured as a loss of 5 points or less in Barthels activities of daily living. Based on the second CGA, patients are re-assigned to their definite treatment arm and undergo further CGAs to monitor the course of treatment. Secondary endpoints include CGA scores during the course of therapy (CGA1-4), response rates, safety and survival rates. DISCUSSION: GrantPax is the first trial implementing a CGA-driven treatment to personalize therapy for elderly patients with pancreatic cancer. This may lead to standardization of therapy decisions for elderly patients and may optimize standard of care for this increasing group of patients.

trial registrationNCT02812992 , registered 24.06.2016.

Indexed as

Geriatric AssessmentAgedAged, 80 and overAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHumansPaclitaxelPancreatic Neoplasms130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabinePaclitaxelComprehensive geriatric assessmentElderlyGeriatric oncologyNab-paclitaxelPancreatic cancerPersonalized medicine

Identifiers

PMID30021548
PMCPMC6052545
OpenAlexW2883172391

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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.