Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Trial Title: Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

NCT ID: NCT05652348

Condition: Gastric Cancer
Colon Cancer
Peritoneal Carcinomatosis

Conditions: Official terms:
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

Conditions: Keywords:
Organoid

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Establishment of organoid cultures and in vitro sensitivity testing
Description: Generating patient-derived tumor organoid models as well as orthotopic mouse models from peritoneal carcinomatosis lesions and to investigate their response to different therapies.

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.

Criteria for eligibility:

Study pop:
Eligible patients are recruited consecutively during of the initial surgical treatment planning

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - (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 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., 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) - Hypersensitivity/allergy to components of the 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 malignant disease that occurred <5 years ago (exception: early stage of a 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 after the end of treatment to become pregnant

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden

Address:
City: Dresden
Country: Germany

Status: Recruiting

Contact:
Last name: Daniel Stange, Prof. Dr.

Facility:
Name: University Hospital Heidelberg

Address:
City: Heidelberg
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Martin Schneider, Prof. Dr.

Start date: December 8, 2022

Completion date: December 31, 2028

Lead sponsor:
Agency: Technische Universität Dresden
Agency class: Other

Collaborator:
Agency: German Cancer Research Center
Agency class: Other

Source: Technische Universität Dresden

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05652348