Status:
UNKNOWN
Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Peritoneal Cancer
Chemotherapy-Induced Change
Eligibility:
All Genders
18+ years
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 ...
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 prot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04122885
Start Date
October 1 2019
End Date
September 30 2022
Last Update
October 10 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Tübingen
Tübingen, Germany, 72076