C16
Conditions
Interventions
Group 1: Patients with locally advanced adenocarcinoma of the stomach or the gastroesophageal junction who are candidates for neoadjuvant chemotherapy undergo, as part of the initial diagnostic workup
Sponsors
Universitätsklinikum Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically confirmed, resectable adenocarcinoma of the gastroesophageal junction or the stomach (cT2–4, cNx, M0 or cTx, cN+, cM0) • Planned administration of neoadjuvant systemic therapy • No contraindications to resection of the primary tumor in the form of a subtotal/total or transhiatal extended gastrectomy or thoracoabdominal esophageal resection • Female and male patients = 18 years of age • Patient is capable of giving informed consent. • Consent also given for future research projects within the framework of research collaborations with other university and non-university institutions
Exclusion criteria
Exclusion criteria: • Patients with distant metastases, including peritoneal carcinomatosis • Patients with recurrence (with or without prior incomplete or complete tumor resection) • Patients who have previously received systemic tumor-specific therapy (such as chemotherapy or targeted therapy) • Patients who, due to their general condition, are not expected to be eligible for surgery • A second malignant disease that occurred < 5 years ago (exception: early-stage localized tumor with in-sano resection, e.g., in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin) • Patients who are housed in a closed facility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The successful establishment of a growth rate for patient-derived organoids of >60% of biopsies per study site | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in the growth rate over time per study site • Establishment of an estimated time to test result for FLOT • Establishment of an estimated time to test results for alternative treatment regimens • Rate of PDOs for which a substance effective on the organoids can be identified as part of a drug screen | — |
Countries
Germany
Contacts
Public ContactDaniel Stange
Universitätsklinikum Dresden
Outcome results
None listed