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

NCT04122885 | Unknown

• 1 other identifier: 392/2018BO1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Cancer; Chemotherapy-Induced Change

Keywords

HIPEC; PIPAC; cytoreductive surgery; immune function; cytokines; plasma proteins

Outcome Measures

Primary Outcomes (1)

• Serum levels of the proteins of interest over time

  6 weeks

Secondary Outcomes (2)

• Postoperative complications

  30 days

• Overall survival

  18 months

Study Arms (2)

CRS and HIPEC

Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy

PIPAC

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

Combination Product: PIPAC with oxaliplatin

Interventions

PIPAC with oxaliplatin COMBINATION_PRODUCT

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

PIPAC

Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy PROCEDURE

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

Also known as: CRS and HIPEC

CRS and HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the institutions involved. All patients must meet inclusion/exclusion criteria (as indicated above) to be considered. Each subject will undergo medical examination during the screening visit (Visit 1) prior to enrolment. The personal data and detailed medical history will be recorded. The screening will take place no more than 6 weeks before intervention. This screening procedure will consist of: * Checking of inclusion/exclusion criteria * Detailed history including medical history * A standard physical examination including the cardiovascular, nervous, respiratory systems, conscience, memory, orientation, and body weight The patient's informed consent for study participation will be signed at the time of enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Links

• University Hospital Tübingen

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Interventions

Oxaliplatin; Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Marc A Reymond, MD MBA

  National Center for Pleura and Peritoneum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc A Reymond, MD MBA

CONTACT

+4970712986722; marc.reymond@med.uni-tuebingen.de

Philipp Horvath, MD

CONTACT

+4970712986620; philipp.horvath@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2022
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

DE (1)