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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 (IMMUNOPAC)

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ClinicalTrials.gov Identifier: NCT04122885
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Peritoneal Cancer Chemotherapy-Induced Change Combination Product: PIPAC with oxaliplatin Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Plasma Tumor-promoting Factors and Immune Function After Explorative Laparotomy, Tumor Debulking and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) vs. PIPAC (Pressurized IntraPeritoneal Aerosol Chemothereapy) in Patients With Peritoneal Metastasis as Evaluated by Serum Proliferative Activity, Levels of Proteins, Cytokines, Circulating Growth Factors, Inhibitors and Their Binding Proteins.
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Group/Cohort Intervention/treatment
CRS and HIPEC
Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C
Other Name: CRS and HIPEC

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




Primary Outcome Measures :
  1. Serum levels of the proteins of interest over time [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
  2. Overall survival [ Time Frame: 18 months ]
    Measured from time point of intervention


Biospecimen Retention:   Samples With DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122885


Contacts
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Contact: Marc A Reymond, MD MBA +4970712986722 marc.reymond@med.uni-tuebingen.de
Contact: Philipp Horvath, MD +4970712986620 philipp.horvath@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Verena Schlaich    +4970712986722    verena.schlaich@med.uni-tuebingen.de   
Sub-Investigator: Rami Archid, MD         
Sub-Investigator: Philipp Horvath, MD         
Sub-Investigator: Giorgi Nadiradze, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Marc A Reymond, MD MBA National Center for Pleura and Peritoneum

Additional Information:
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04122885     History of Changes
Other Study ID Numbers: 392/2018BO1
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD might be shared on request after completion of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
HIPEC
PIPAC
cytoreductive surgery
immune function
cytokines
plasma proteins
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Oxaliplatin
Antineoplastic Agents