Study Stopped
Sponsor Decision
The PLATON Network
PLATON
The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)
1 other identifier
observational
565
1 country
31
Brief Summary
The PLATON Network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. Hereby, PLATON's study-design focuses on the patient's tumor molecular profiling. Within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at PLATON's study sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2020
CompletedFirst Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFebruary 5, 2026
February 1, 2026
4.7 years
May 31, 2022
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of targetable mutations in gastrointestinal cancer patients
Relative frequency of targetable mutations computed as the number of patients who harbor at least one mutation divided by the number of total patients in the analyzed patient population
annual interim-analysis (1 year)
Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients
Number of received therapies in or out accordance to genomic profiles
annual interim-analysis (1 year)
Secondary Outcomes (7)
Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients
annual interim-analysis (1 year)
QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients
annual interim-analysis (1 year)
QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients
annual interim-analysis (1 year)
QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients
annual interim-analysis (1 year)
QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients
annual interim-analysis (1 year)
- +2 more secondary outcomes
Other Outcomes (1)
Feasibility of the PLATON WebApp - an interactive platform that connects the participating physicians on cases, cancer types, mutations, protein expressions and therapies, possible trials and discussion options for medical professionals
through study completion, an average of 2 years
Study Arms (4)
HCC (Hepatocellular cancer)
Hepatocellular cancer patients with NGS based molecular tumor profiling
CCA/GBCA (Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer)
Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer patients with NGS based molecular tumor profiling
PanCa (Pancreatic cancer)
Pancreatic cancer patients with NGS based molecular tumor profiling
EC/GC (Oesophagogastric cancer)
Oesophagogastric cancer patients with NGS based molecular tumor profiling
Eligibility Criteria
The PLATON Network and its associated pilot study (clinicaltrials.gov:. NCT04484636) enrolls national-wide participants of both sexes and ages over 18 years. All participants are patients diagnosed with hepatocellular cancer (HCC) or intra-/extrahepatic cholangiocellular carcinoma (CCA) or gallbladder carcinoma (GBCA) or pancreatic cancer (PanCa) or esophagogastric cancer (EC/GC). At the time of enrolment life expectancy is at least 6 months and no local curative therapy is available.
You may qualify if:
- Histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available
- Standard first line therapy is planned, or patient is currently receiving first-line therapy
- Available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study
- ECOG 0-2
- Life expectancy ≥ 6 months
You may not qualify if:
- Not able to understand all implications of study participation
- No written informed consent
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
KHNW Frankfurt
Frankfurt am Main, Hesse, 60488, Germany
Friedrich-Ebert-Krankenhaus Neumünster
Neumünster, Schleswig-Holstein, 24534, Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany
Evangelisches Waldkrankenhaus Spandau
Berlin, Germany
MVZ Oskar-Helene-Heim Berlin
Berlin, Germany
Augusta-Kranken-Anstalt Bochum
Bochum, Germany
Bochum Uni
Bochum, Germany
Klinikum Chemnitz
Chemnitz, Germany
GEFOS - Gesellschaft für onkologische Studien Dortmund
Dortmund, Germany
Onkozentrum Dresden
Dresden, Germany
Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie
Essen, 45136, Germany
MVZ Onkologische Kooperation Harz
Goslar, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Hamburg Onkologische Schwerpunktpraxis Eppendorf
Hamburg, Germany
St. Anna Hospital Herne
Herne, Germany
Ortenau Klinikum Lahr-Ettenheim
Lahr, Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
Landshut, Germany
Langen, Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Germany
Studienzentrum UnterEms
Leer, Germany
Klinikum Lippe
Lemgo, Germany
Klinikum Ludwigsburg
Ludwigsburg, Germany
Klinik München-Bogenhausen
München, Germany
Münster, Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, Germany
Medius Klinik Osterfildern-Ruit
Ostfildern, Germany
Krankenhaus Barmherzige Brüder
Regensburg, Germany
Klinikum Rheine, Mathias-Spital Rheine
Rheine, Germany
CaritasKlinikum Saarbrücken
Saarbrücken, Germany
Onkologie Bodensee
Singen, Germany
Marien Hospital Witten
Witten, Germany
Klinikum Wolfsburg
Wolfsburg, Germany
Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH
Wolfsburg, Germany
Related Links
Biospecimen
Whole blood, serum and plasma, formalin-fixed paraffin-embedded tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Salah-Eddin Al-Batran, Prof. Dr.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- PRINCIPAL INVESTIGATOR
Arndt Vogel, Prof. Dr.
Hannover Medical School (MHH)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
August 5, 2022
Study Start
October 28, 2020
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Access Criteria
- PLATON's Use und Access Regulation is available upon individual request for PLATON Network members and cooperation partners. For more information on contact please visit the PLATON Network website.
Depending on participant informed consent individual-participant data (IPD) will be shared in research-cooperations according the terms of PLATON's Use and Access Regulation for scientific and/or educational use. Scientific/ educational projects have to be approved by PLATON'S Scientific Steering Committee.