Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in gastro-intestinal Cancer (Hi-STEP1)

Recruiting

• Conditions: C16; C18; C48; Malignant neoplasm of stomach; Malignant neoplasm of colon; Malignant neoplasm of retroperitoneum and peritoneum

• Registration Number: DRKS00028836
• Lead Sponsor: Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. AEG) 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 min. 6 months

- 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., Z.n. peritonectomy in the setting 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 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 malignancy that occurred <5 years ago (exception: early stage 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 of the end of treatment.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to analyze the predictive accuracy of patient-generated tumor organoids (PDOs) for predicting response to HIPEC treatment in patients with peritoneal carcinomatosis (PC).

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are:<br>1. to describe individualized HIPEC regimens in vitro based on organoid therapy response and next generation sequencing (NGS) data.<br>2. to evaluate individualized HIPEC regimens in vivo in an orthotopic mouse model.