Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment approach for patients with gastric or colon cancer that has spread to the lining of the abdomen, a condition known as peritoneal carcinomatosis. During their main surgery, patients will have a small sample of their tumor taken for testing in the lab. The researchers will grow these samples into mini-tumors called organoids and test different chemotherapy drugs on them to discover which treatments might work best for each patient's cancer. They will also look for specific genetic changes in the tumors that could be targeted with special drugs.

To participate in this trial, patients need to have confirmed cancer with peritoneal spread, and they should be eligible for surgery to remove as much of the cancer as possible. They also need to be in generally good health and able to give consent for the study. If eligible, participants can expect to undergo standard surgery followed by a unique treatment called HIPEC, where heated chemotherapy is delivered directly to the abdomen. This trial is important because it aims to personalize cancer treatment based on individual tumor characteristics, potentially improving outcomes for patients.

Gender

ALL

Eligibility 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

Trial Officials