Pancreatic Cancer Clinical Trial
— PLATONOfficial 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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
Germany,
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) |
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