Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (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

• No contraindication to surgery

• No contraindication against the performance of HIPEC

• Expected survival of 6 months at least

• 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

Locations
Other Locations
Germany
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
RECRUITING
Dresden
University Hospital Heidelberg
NOT_YET_RECRUITING
Heidelberg
Contact Information
Primary
Daniel Stange, Prof. Dr.
daniel.stange@ukdd.de
+49 351 458 4098
Time Frame
Start Date: 2022-12-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 48
Sponsors
Leads: Technische Universität Dresden
Collaborators: German Cancer Research Center

This content was sourced from clinicaltrials.gov