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Information sheet on the clinical trial - PLATON

Main indication

Gastrointestinal tumors

 

Study name (study type)

PLATON (Diagnostic Platform)

 

Study sponsor

IKF Ffm

 

Registration number

ClinicalTrials.gov Identifier: NCT04484636

 

FOR RUSH READERS:

Study for patients with hepatocellular carcinoma, intra-/extrahepatic cholangiocarcinoma, gallbladder carcinoma, ductal pancreatic adenocarcinoma, or esophagogastric adenocarcinoma. Treatment data, questionnaires, and tissue samples from the patients’ tumors will be collected. This is an observational study and has no influence on the treatment method prescribed by the physician.

 

DETAILED INFORMATION

 

Study Title

A multicenter, prospective observational study to evaluate genetic tumor profiles and associated treatment decisions in the oncology of gastrointestinal tumors

 

Which diseases are being treated in this study?

Gastrointestinal tumors

 

Are specific subgroups of patients with any of the mentioned diseases being treated?

Patients with hepatocellular carcinoma, intra-/extrahepatic cholangiocarcinoma, gallbladder carcinoma, ductal pancreatic adenocarcinoma, or esophagogastric adenocarcinoma

 

Background on the study medication

None

 

Study procedure.

Patients are examined regularly, and their tumor tissue and blood are specifically tested for genetic changes (so-called mutations) that are believed to be relevant to tumor growth and treatment. Observation time points: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years, 6 years, 8 years, 10 years.

 

Inclusion criteria

  • Histologically confirmed diagnosis of advanced-stage hepatocellular carcinoma (HCC),  intra-/extrahepatic cholangiocarcinoma (CCA), gallbladder carcinoma (GBCA), ductal pancreatic adenocarcinoma (PDCA), or esophagogastric adenocarcinoma (EC/GC)
  • No local curative therapy available; adjuvant or neoadjuvant therapy is permitted if it was completed at least 6 months prior to enrollment
  • Standard first-line therapy is planned or is being received
  • ECOG performance status is 0–2

 

Exclusion criteria

  • Age < 18 years
  • Patients who do not meet the inclusion criteria

 

Your contacts: Investigators at the center and contact information

Prof. Dr. Dimitri Flieger

Email: flieger@~@gp-ruesselsheim.de

Phone: 06142 88-1456

 

Responsible staff members in the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032

Clinical studies and medical documentation