C16 C18 C48
Conditions
Interventions
Group 1: During primary curative surgery for gastric or colon carcinoma with synchronous or metachronous peritoneal carcinomatosis, the peritoneal carcinomatosis index (PCI) is determined and biopsies
Sponsors
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. AEG) or colon carcinoma (incl. rectal carcinoma) - Intraoperative peritoneal cancer index (PCI) = 15 for gastric carcinoma and = 20 for colon carcinoma. - Possibility of surgical resection of peritoneal carcinomatosis (cytoreductive surgery) in curative intention with achievement of a Completeness of Cytoreduction Score (CCS) of 0-1 - no contraindication to surgery - no contraindication against the performance of HIPEC - Expected survival of min. 6 months - ECOG = 2 - Female and male patients = 18 years of age - Patient is able and willing to give written informed consent and comply with the study protocol.
Exclusion criteria
Exclusion criteria: - Presence of non-resectable distant metastases. - Patients with extensive metastasis (e.g., multiple bilobular liver metastases, hepatic and pulmonary metastases, multiple retroperitoneal lymph node metastases; oligometastasis is allowed) - Patients with recurrence of peritoneal carcinomatosis (e.g., Z.n. peritonectomy in the setting of primary tumor resection) - Patients after previous palliative chemotherapy or radiation of the tumor (exception: neoadjuvant and/or adjuvant therapies) - hypersensitivity/allergy to components of planned intraperitoneal chemotherapy - Patients not eligible for surgery/HIPEC (e.g., heart failure NYHA =III, myocardial infarction within the last 3 months before surgery, high-risk cardiac arrhythmias) - 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 - Pregnant or breastfeeding patients, or patients who plan to become pregnant within 7 months of the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to analyze the predictive accuracy of patient-generated tumor organoids (PDOs) for predicting response to HIPEC treatment in patients with peritoneal carcinomatosis (PC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1. to describe individualized HIPEC regimens in vitro based on organoid therapy response and next generation sequencing (NGS) data. 2. to evaluate individualized HIPEC regimens in vivo in an orthotopic mouse model. | — |
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