C16 C15
Conditions
Interventions
Group 1: Patients with adenocarcinoma of the stomach or gastroesophageal junction who are scheduled for neoadjuvant chemotherapy.
Prior to neoadjuvant therapy, several biopsies of the tumor are take
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically confirmed, resectable adenocarcinoma of the gastroesophageal junction or stomach (cT2-4 cNx M0 or cTx cN+ cM0). - ECOG score = 2 - Planned implementation of neoadjuvant systemic therapy. - No contraindication to resection of the primarius in terms of subtotal/total or transhiatal extended gastrectomy or thoracoabdominal esophageal resection. - Exclusion of distant metastases by imaging of thorax/abdomen. - Female and male patients = 18 years of age. - Laparoscopic exclusion of peritoneal carcinomatosis if clinically suspected. - Patient is capable of giving consent.
Exclusion criteria
Exclusion criteria: - Patients with distant metastases incl. peritoneal carcinomatosis - Patients with recurrence (with or without previous incomplete/complete tumor resection) - Patients with previous systemic tumor-specific therapy (such as chemotherapy or targeted therapy) - Hypersensitivity/allergy to components of the planned neoadjuvant therapy. - Patients who cannot undergo surgery due to their general condition - Secondary malignancy that occurred < 5 years ago (exception: early stage localized tumor with in-sano resection, for example, 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 primary objective of the study is to define an alternative therapeutic regimen based on PDOs unresponsive to FLOT that demonstrates efficacy in more than 90% of PDOs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the study are: To demonstrate that the response to treatment of pretherapeutic PDOs (before neoadjuvant chemotherapy) is comparable to that of posttherapeutic PDOs (after neoadjuvant chemotherapy) for each patient. Other translational research objectives: - To detect clonal evolution under therapy using PDOs. - To model therapy-induced treatment resistance by long-term Treatment of PDOs. - To understand the social implications and ethical challenges of the Use of PDOs. | — |
Countries
Germany
Contacts
Public ContactDaniel Stange
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Outcome results
None listed