Predicting responses to chemotherapy in gastrointestinal cancer using organoids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves patients with gastric or colon cancer who have peritoneal carcinomatosis. During their primary surgery, a biopsy will be taken to create organoid cultures in the laboratory. Various chemotherapy agents will be tested on these organoids to evaluate their sensitivity and analyze genetic alterations that may be targeted with specific drugs. The goal is to improve treatment outcomes for patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC).

Why it matters

Who can join: the full rules

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

Where it's running

• Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
  Berlin, Germany Recruiting
• Universitätsklinikum Köln (AöR), Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
  Cologne, Germany Recruiting
• Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
  Dresden, Germany Recruiting
• Universitätsklinikum Würzburg, Chirurgie I - Klink und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie
  Würzburg, Germany Recruiting
• Universitätsklinikum Ulm, Klink für Innere Medizin I
  Ulm, Germany Not yet recruiting

Study contacts

• Principal investigator: Daniel Stange, Prof. Dr. — University Hospital Carl Gustav Carus Dresden
• Study coordinator: Daniel Stange, Prof. Dr.
• Email: daniel.stange@ukdd.de
• Phone: +49 351 458 4098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.