The PLATON Network

Pancreatic Cancer Clinical Trial

— PLATON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489250
• Other study ID #: The PLATON Network
• Status: Recruiting
• Start date: October 28, 2020
• Est. completion date: May 31, 2032

Study information

• Verified date: December 2023
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: Salah-Eddin Al-Batran, Prof. Dr.
• Phone: +49 (0)69-7601-4420
• Email: platon[@]ikf-khnw.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2032
• Est. primary completion date: May 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms
• Hepatocellular Cancer
• Liver Neoplasms
• Oesophageal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
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
Germany	KHNW Frankfurt	Frankfurt	Hessen
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	Friedrich-Ebert-Krankenhaus Neumünster	Neumünster	Schleswig-Holstein
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

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	The feasibility will be analyzed with a usability questionnaire regarding user experience, design criteria etc. of the newly designed infrastructure and an additional count on possible matches of cancer patients with defined genetic tumor-profiles to possible targeted therapy strategies.	through study completion, an average of 2 years
Primary	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)
Primary	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	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.	annual interim-analysis (1 year)
Secondary	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	annual interim-analysis (1 year)
Secondary	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.	annual interim-analysis (1 year)
Secondary	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".	annual interim-analysis (1 year)
Secondary	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.	annual interim-analysis (1 year)
Secondary	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.	annual interim-analysis (1 year)
Secondary	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.	annual interim-analysis (1 year)

External Links

•   The PLATON Network - Data Capture (for PLATON study team members only)
•   The PLATON Network - PLATON WebApp (web-application for PLATON network members only)
•   The PLATON Network - website with study information (public)