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Hi-STEP1: Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Sponsor
Technische Universität Dresden (Other)
Overall Status
Recruiting
CT.gov ID
NCT05652348
Collaborator
Deutsches Krebsforschungszentrum (DKFZ) (Other)
48
Enrollment
2
Locations
72.8
Anticipated Duration (Months)
24
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Establishment of organoid cultures and in vitro sensitivity testing

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2028

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the sensitivity of the in vitro response of the organoid model to chemotherapeutic agents [1 year]

    Organoid treatment by means of ascending doses of chemotherapy and under HIPEC conditions, i.e. with elevated temperature

  2. Next generation sequencing of organoid cultures [1 year]

    Sequencing of DNA and RNA (Ribonucleic acid)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden Dresden Germany
2 University Hospital Heidelberg Heidelberg Germany

Sponsors and Collaborators

  • Technische Universität Dresden
  • Deutsches Krebsforschungszentrum (DKFZ)

Investigators

  • Principal Investigator: Daniel Stange, Prof. Dr., University Hospital Carl Gustav Carus Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT05652348
Other Study ID Numbers:
  • VTG-12
First Posted:
Dec 15, 2022
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Technische Universität Dresden
Organoid
Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

Study Results

No Results Posted as of Jan 12, 2023