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

Last updated: October 9, 2019
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Malignant Ascites

Peritoneal Cancer

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT04122885
392/2018BO1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Adult patients (18 years of age or older) with ovarian, gastric, or colorectal cancer whohave 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 ofTubingen are eligible for entry in this study

Exclusion

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 duringthe first 2 weeks after surgery.

  • History of allergic reaction to cisplatin or other platinum containing compounds ordoxorubicin

  • Severe renal impairment, myelosuppression, severe hepatic impairment, severemyocardial insufficiency, recent myocardial infarction, severe arrhythmias

  • Immunocompromised patients such as those taking an immunosuppressive medication andthose who have a known disease of the immune system

  • Patients or family members involved in the planning and conduct of the study (appliesto University of Tübingen staff involved)

  • Pregnancy

Study Design

Total Participants: 60
Study Start date:
October 01, 2019
Estimated Completion Date:
September 30, 2022

Study 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.

Connect with a study center

  • University Hospital Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

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