AzTrials
AzTrials

Hepatocellular CancerPLATONNCT05489250

The PLATON Network

An observational study of Hepatocellular Cancer and Cholangiocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 31 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
565 participants
Where
31 sitesGermany
Study dates
28 Oct 2020to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • Not able to understand all implications of study participation
  • No written informed consent
  • Age < 18 years

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Germany31 sites

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

  • Evangelisches Waldkrankenhaus Spandau

    Berlin

  • MVZ Oskar-Helene-Heim Berlin

    Berlin

  • Augusta-Kranken-Anstalt Bochum

    Bochum

  • Bochum Uni

    Bochum

  • Klinikum Chemnitz

    Chemnitz

  • GEFOS - Gesellschaft für onkologische Studien Dortmund

    Dortmund

  • Onkozentrum Dresden

    Dresden

  • Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie

    Essen, 45136

  • KHNW Frankfurt

    Frankfurt am Main, Hesse, 60488

  • MVZ Onkologische Kooperation Harz

    Goslar

  • Universitätsklinikum Halle (Saale)

    Halle

  • Hamburg Onkologische Schwerpunktpraxis Eppendorf

    Hamburg

  • St. Anna Hospital Herne

    Herne

  • Ortenau Klinikum Lahr-Ettenheim

    Lahr

  • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH

    Landshut

  • Langen, Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen

  • Studienzentrum UnterEms

    Leer

  • Klinikum Lippe

    Lemgo

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Klinik München-Bogenhausen

    München

  • Münster, Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster

  • Friedrich-Ebert-Krankenhaus Neumünster

    Neumünster, Schleswig-Holstein, 24534

  • Medius Klinik Osterfildern-Ruit

    Ostfildern

  • Krankenhaus Barmherzige Brüder

    Regensburg

  • Klinikum Rheine, Mathias-Spital Rheine

    Rheine

  • CaritasKlinikum Saarbrücken

    Saarbrücken

  • Onkologie Bodensee

    Singen

  • Marien Hospital Witten

    Witten

  • Klinikum Wolfsburg

    Wolfsburg

  • Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH

    Wolfsburg

Other trials in Germany

About this study

Official title: The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)

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.

Read the detailed description

The PLATON Network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. The study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects.

Within PLATON results of genetic tests of different research projects like the PLATON pilot-study (NCT04484636) as well as Next-generation deep sequencing (NGS) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (TMB) and microsatellite instability (MSI).

The PLATON Network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. Therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. The feasibility of this approach will be tested in the PLATON Network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.

Keywords
Gastric cancer, Individualized cancer therapy, Targetable mutations, NGS, Hepatocellular Cancer, Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, Oesophageal Cancer, Stomach Cancer, Platform-Design, Biobanking
Medical subject headings
Liver Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05489250
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: annual interim-analysis (1 year)

  2. Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients

    Number of received therapies in or out accordance to genomic profiles

    Measured: annual interim-analysis (1 year)

Secondary outcomes (7)

  1. Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients

    Overall survival measurement over time grouped by diagnostic cohorts and adjusted by age and sex will be correlated to treatments, while genomic profiles had or had not impact on decision for treatment.

    Measured: annual interim-analysis (1 year)

  2. QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients

    QoL measurements are done over time in the palliative setting. Gastrointestinal cancer patient cohorts will be grouped by diagnostics and adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment in gastrointestinal cancer patients.

    EQ-5D data is used in summary statistics at each observational timepoint and to estimate the difference between health states like "Mobility", "Looking After Myself", "Doing Usual Activities", "Having Pain or Discomfort", "Feeling Worried, Sad or Unhappy" in diagnostic groups of different treatments over time. The EQ VAS (visual analogue scale) on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health) indicates patients´ overall health on the day of questionnaire completion and will be used as measure of central tendency and dispersion

    Measured: annual interim-analysis (1 year)

  3. QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients

    QoL measurements are done over time in the palliative setting. Gastrointestinal cancer patient cohorts will be grouped by diagnostics and adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment in gastrointestinal cancer patients.

    EORTC QLQ-C30 data is used in summary statistics at each observational timepoint to analyze five function subscales (physical, role, emotional, cognitive and social), nine symptom subscales/items (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties) and a global health/ QoL subscale following the QLQ-C30 scoring manual.

    Measured: annual interim-analysis (1 year)

  4. QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients

    QoL measurements are done over time in the palliative setting. The CCA and GBCA patients cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.

    QoL in CCA and GBCA patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-BIL21 and analyzed according validated manual, forming nine symptom subscales/items for "Eating", "Jaundice", "Tiredness", "Pain" and "Anxiety".

    Measured: annual interim-analysis (1 year)

  5. QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients

    QoL measurements are done over time in the palliative setting. The HCC patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.

    QoL in HCC patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-HCC18 and analyzed according validated manual, forming symptom scales for "Fatigue", "Body Image", "Jaundice", "Nutrition", "Pain" and "Fever" as well as single items like "Abdominal swelling" and "Sex life" in summary statistics at each observational timepoint.

    Measured: annual interim-analysis (1 year)

  6. QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients

    QoL measurements are done over time in the palliative setting. The PDCA patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.

    QoL in PDCA patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-PAN26 and analyzed according validated manual, forming eight scales to assess "Pancreatic pain", "Digestive symptoms", "Altered bowel habit", "Hepatic, body image", "Satisfaction with health care", and "Sex life" in summary statistics at each observational timepoint.

    Measured: annual interim-analysis (1 year)

  7. QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients

    QoL measurements are done over time in the palliative setting. The EC/GC patient cohort will be adjusted by age and sex, correlated to treatments, while genomic profiles had or had not impact on decision for treatment.

    QoL in EC/GC patients will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire QLQ-STO22 and analyzed according validated manual, forming five multi-item scales to assess "dysphagia", "pain", "reflux", "eating" and "anxiety" as well as four single items like "dry mouth", "taste", "body image" and "hair loss" in summary statistics at each observational timepoint.

    Measured: annual interim-analysis (1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start28 Oct 2020
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489250
Sponsor's protocol ID
The PLATON Network
Acronym
PLATON
Status last verified
Feb 2026
First submitted
31 May 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Cancer and Cholangiocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 31 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of targetable mutations in gastrointestinal cancer patients (time frame: annual interim-analysis (1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in