Clinical trial NCT05489250: The PLATON Network
Official title: The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Keywords: Gastric cancer
Individualized cancer therapy
Targetable mutations
NGS
Hepatocellular Cancer
Cholangiocarcinoma
Gallbladder Cancer
Pancreatic Cancer
Oesophageal Cancer
Stomach Cancer
Platform-Design
Biobanking
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Frequency of targetable mutations in gastrointestinal cancer patients
timeFrame: annual interim-analysis (1 year)
measure: Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients
timeFrame: annual interim-analysis (1 year)
Secondary outcomes:
measure: Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients
timeFrame: annual interim-analysis (1 year)
measure: QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients
timeFrame: annual interim-analysis (1 year)
Other outcomes:
measure: 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
timeFrame: through study completion, an average of 2 years
Locations:
city: Frankfurt
country: Germany
facility: KHNW Frankfurt
state: Hessen
city: Neumünster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Neumünster
state: Schleswig-Holstein
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Berlin
country: Germany
facility: MVZ Oskar-Helene-Heim Berlin
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum
city: Bochum
country: Germany
facility: Bochum Uni
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Dortmund
country: Germany
facility: GEFOS - Gesellschaft für onkologische Studien Dortmund
city: Dresden
country: Germany
facility: Onkozentrum Dresden
city: Essen
country: Germany
facility: Ev. Kliniken Essen-Mitte, Klinik für Internistische Onkologie
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Hamburg Onkologische Schwerpunktpraxis Eppendorf
city: Herne
country: Germany
facility: St. Anna Hospital Herne
city: Lahr
country: Germany
facility: Ortenau Klinikum Lahr-Ettenheim
city: Landshut
country: Germany
facility: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
city: Langen
country: Germany
facility: Langen, Gemeinschaftspraxis für Hämatologie und Onkologie
city: Leer
country: Germany
facility: Studienzentrum UnterEms
city: Lemgo
country: Germany
facility: Klinikum Lippe
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: München
country: Germany
facility: Klinik München-Bogenhausen
city: Münster
country: Germany
facility: Münster, Gemeinschaftspraxis für Hämatologie und Onkologie
city: Ostfildern
country: Germany
facility: Medius Klinik Osterfildern-Ruit
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Rheine
country: Germany
facility: Klinikum Rheine, Mathias-Spital Rheine
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken
city: Singen
country: Germany
facility: Onkologie Bodensee
city: Witten
country: Germany
facility: Marien Hospital Witten
city: Wolfsburg
country: Germany
facility: Klinikum Wolfsburg
city: Wolfsburg
country: Germany
facility: Onkologisches Zentrum Wolfsburg-Helmstedt MVZ GmbH
Study officials:
affiliation: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
name: Salah-Eddin Al-Batran, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Hannover Medical School (MHH)
name: Arndt Vogel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: