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JOURNAL ONKOLOGIE – STUDIE
PLATON

The PLATON Network

Rekrutierend

NCT-Nummer:
NCT05489250

Studienbeginn:
Oktober 2020

Letztes Update:
08.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Stomach Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
-

Studienleiter

Salah-Eddin Al-Batran, Prof. Dr.
Study Director
Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
Arndt Vogel, Prof. Dr.
Principal Investigator
Hannover Medical School (MHH)

Kontakt

Studienlocations
(3 von 31)

Onkologisches Zentrum - Krankenhaus Barmherzige Brüder Regensburg
Prüfeninger Straße 86
93049 Regensburg
(Bayern)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Nicolas Moosmann, Dr.

Christiane Reinert» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Frequency of targetable mutations in gastrointestinal cancer patients (Time Frame - annual interim-analysis (1 year)):
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

2. Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients (Time Frame - annual interim-analysis (1 year)):
Number of received therapies in or out accordance to genomic profiles

Secondary outcome:

1. Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients (Time Frame - annual interim-analysis (1 year)):
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.

2. QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients (Time Frame - annual interim-analysis (1 year)):
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

3. QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients (Time Frame - annual interim-analysis (1 year)):
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.

4. QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients (Time Frame - annual interim-analysis (1 year)):
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".

5. QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients (Time Frame - annual interim-analysis (1 year)):
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.

6. QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients (Time Frame - annual interim-analysis (1 year)):
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.

7. QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients (Time Frame - annual interim-analysis (1 year)):
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.

Studien-Arme

  • 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

Quelle: ClinicalTrials.gov


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