Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

NCT05652348 | Recruiting

• 1 other identifier: VTG-12
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastric Cancer; Colon Cancer; Peritoneal Carcinomatosis

Keywords

Organoid

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• Next generation sequencing of organoid cultures

  Sequencing of DNA and RNA (Ribonucleic acid)

  1 year

Interventions

Establishment of organoid cultures and in vitro sensitivity testing OTHER

Generating patient-derived tumor organoid models as well as orthotopic mouse models from peritoneal carcinomatosis lesions and to investigate their response to different therapies.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Cancer Research Center: collaborator

Study Sites (2)

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

Dresden, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples of tumor taken during standard of care

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Study Officials

• Daniel Stange, Prof. Dr.

  University Hospital Carl Gustav Carus Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Stange, Prof. Dr.

CONTACT

+49 351 458 4098; daniel.stange@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: December 8, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)