Predicting responses to chemotherapy in gastrointestinal cancer using organoids
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Technische Universität Dresden · NCT05652348
This study is testing if lab-grown mini tumors from patients with gastric or colon cancer can help doctors find the best chemotherapy drugs to improve treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Dresden and 1 other locations) |
| Trial ID | NCT05652348 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with resectable peritoneal carcinomatosis from gastric or colon cancer.
Not a fit: Patients with non-resectable distant metastases or contraindications to surgery or HIPEC may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with gastrointestinal cancers.
How similar studies have performed: While the use of organoids for drug sensitivity testing is gaining traction, this specific approach in the context of HIPEC for gastrointestinal cancers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden and 1 other locations
- Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden — Dresden, Germany (RECRUITING)
- University Hospital Heidelberg — Heidelberg, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, Colon Cancer, Peritoneal Carcinomatosis, Organoid