Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory.
Various chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(Suspected) synchronous or metachronous peritoneal metastasis of adenocarcinoma of the stomach / gastroesophageal junction (GEJ) or of the colon or rectum
intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. GEJ) 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
Disqualifiers
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., previous peritonectomy in the course of primary tumor resection)
Patients after previous palliative chemotherapy or radiation of the tumor (exception: neoadjuvant and/or adjuvant therapies)
Trial population
Eligible patients are recruited consecutively during of the initial surgical treatment planning
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Establishment of organoid cultures and in vitro sensitivity testing
Other interventionGenerating patient-derived tumor organoid models as well as orthotopic mouse models from peritoneal carcinomatosis lesions and to investigate their response to different therapies.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluation of the sensitivity of the in vitro response of the organoid model to chemotherapeutic agents
Organoid treatment by means of ascending doses of chemotherapy and under HIPEC conditions, i.e. with elevated temperature
Time frame
1 year2
Next generation sequencing of organoid cultures
Sequencing of DNA and RNA (Ribonucleic acid)
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator
Source ClinicalTrials.gov