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

NCT04122885 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-10-10

No results posted yet for this 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.

Conditions

  • Peritoneal Cancer
  • Chemotherapy-Induced Change

Interventions

COMBINATION_PRODUCT

PIPAC with oxaliplatin

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

PROCEDURE

Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy

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

Sponsors & Collaborators

Principal Investigators

  • Marc A Reymond, MD MBA · National Center for Pleura and Peritoneum

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-09-30
Completion
2022-09-30

Countries

  • Germany

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122885 on ClinicalTrials.gov