Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis

• Conditions: Chemotherapy-Induced Change; Peritoneal Cancer
• Interventions: Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy; Combination Product: PIPAC with oxaliplatin

• Registration Number: NCT04122885
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The general goal of this study is to investigate the effect of treatment on serum concentrations of proteins known to impact angiogenesis or tumor growth and establishment in patients with peritoneal metastasis of various origin. Since the immune system is thought, by many, to have an impact on tumor growth and development, this study also seeks to determine the impact of abdominal surgery on postoperative immune function in PM patients, as judged by proteins known to influence immune function. This study will not only characterize the postoperative plasma but also to determine if the magnitude of any of the changes noted is associated with a worse or improved oncologic outcome.

The principle purpose of this study is to gather perioperative serum/plasma samples from patients with PM from a variety of different primary tumors (ovarian, gastric, and colorectal) undergoing either CRS and HIPEC versus PIPAC.

Detailed Description

The plasma samples obtained in this protocol will also be used to study the various plasma proteins that influence immune function as well as those that influence angiogenesis. In addition to the proteins mentioned above, there are also a large number of other proteins that have not been investigated thus far in the perioperative window; these proteins also merit assessment. The plasma obtained via this study and protocol will also be used to search for other tumor growth factors influenced by surgery or to investigate the impact of surgery on immune function.

Aim 1: To determine perioperative serum levels, over time, of a variety of serum proteins including but not limited to IGFBP-3, VEGF, Ang 2, PlGF, sVCAM, CHI3L1, MMP-2, MMP-3, MCP-1 and proteins that influence immune function as well as other proteins in the following 2 groups of patients:

1. PM patients treated with CRS and HIPEC

2. PM patients treated with PIPAC.

Aim 2: To compare the perioperative blood protein results between the 2 different groups of patients.

Aim 3: To determine, within each group, a possible correlation between the magnitude of these effects on oncological outcome (patient overall survival).

Aim 4: To search for other surgery-influenced plasma or cellular factors that may influence early postoperative tumor growth or that hold promise as tumor or prognostic markers.

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-01
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10
• Primary Completion: 2020-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult patients (18 years of age or older) with ovarian, gastric, or colorectal cancer who have PM who after thorough evaluation are deemed candidates for:

• CRS & HIPEC if complete cytoreductive surgery is possible (OR)
• PIPAC if no complete cytoreductive surgery is possible at the University Hospital of Tubingen are eligible for entry in this study

Exclusion Criteria

• ASA 3 & 4 patients
• Patients who have received chemotherapy within 1 month prior to the planned surgery
• Patients who have received blood transfusion(s) within 2 weeks of the planned surgery
• Patients in whom the treatment plan includes systemic chemotherapy to be given during the first 2 weeks after surgery.
• History of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
• Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias
• Immunocompromised patients such as those taking an immunosuppressive medication and those who have a known disease of the immune system
• Patients or family members involved in the planning and conduct of the study (applies to University of Tübingen staff involved)
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRS and HIPEC	Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy	Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
PIPAC	PIPAC with oxaliplatin	Pressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible)

Primary Outcome Measures

Name	Time	Method
Serum levels of the proteins of interest over time	6 weeks

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days
Overall survival	18 months	Measured from time point of intervention

Trial Locations

Locations (1)

University Hospital Tübingen; 🇩🇪 Tübingen, Germany