Peritoneal Cancer Clinical Trial
— IMMUNOPACOfficial 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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Icahn School of Medicine at Mount Sinai |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum levels of the proteins of interest over time | 6 weeks | ||
Secondary | Postoperative complications | 30 days | ||
Secondary | Overall survival | Measured from time point of intervention | 18 months |
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