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

NCT ID: NCT04122885

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-09-30

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.

Conditions

Peritoneal Cancer; Chemotherapy-Induced Change

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CRS and HIPEC

Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy

Intervention Type: PROCEDURE

If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C

PIPAC

Pressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible)

PIPAC with oxaliplatin

Intervention Type: COMBINATION_PRODUCT

Oxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure

Interventions

PIPAC with oxaliplatin

Oxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure

Intervention Type: COMBINATION_PRODUCT

Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy

If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C

Intervention Type: PROCEDURE

Other Intervention Names

CRS and HIPEC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc A Reymond, MD MBA

Role: PRINCIPAL_INVESTIGATOR

National Center for Pleura and Peritoneum

Locations

University Hospital Tübingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marc A Reymond, MD MBA

Role: CONTACT

marc.reymond@med.uni-tuebingen.de

+4970712986722

Philipp Horvath, MD

Role: CONTACT

philipp.horvath@med.uni-tuebingen.de

+4970712986620

Facility Contacts

Verena Schlaich

Role: primary

verena.schlaich@med.uni-tuebingen.de

+4970712986722

Related Links

https://www.medizin.uni-tuebingen.de/en-de/startseite

University Hospital Tübingen

Other Identifiers

392/2018BO1

Identifier Type: -

Identifier Source: org_study_id