Intraoperative Chemotherapy is used after a complete macroscopic removal of peritoneal metastases ( peritonectomy ) to kill tumor cells remaining free or minimal residual residual tumor . This allows an improved overall survival compared with a sole systemic chemotherapy can be achieved.
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemcitabine
Pharmaceutical Form: Powder for solution for infusion
Sponsors
University Department of General, Visceral and Transplant Surgery Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: = 18 years • CT morphologically suspected pancreatic tumor without distant metastases , with the possibility of a macroscopically complete resection ( R0 / R1 ) . • Histological diagnosis of adenocarcinoma of the pancreas ' in the frozen section intraoperatively • Karnofsky Index > 70 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • Patients who are considered inoperable because of reduced general condition: - Congestive heart failure (NYHA III / IV) - Severe coronary heart disease, non-treatable arrhythmia or non-adjustable hypertension, - Severe asthma suffering (COPD) - Renal insufficiency (serum creatinine = 1.5x of normal, or creatinine clearance 0) • Patients with a contraindication related to the present study • allergy or intolerance to the study drug or a substance with chemical similarity to the study medication. • Patients under legal custodianship (For Example for significant psychiatric disabilities, etc.) or incarcerated patients • Patients That can not understand the purpose of the study due to mental, intellectual or linguistic problem. • Participation in Clinical Trials or other observation period of competing trials. • Females during pregnancy and lactation • Females of childbearing potential (FCBP) That do not agree - To utilize two reliable forms of contraception or practice complete abstinence from Simultaneously heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment - To abstain from breastfeeding during study participation and 6 months after study treatment. • Males That do not agree -to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days study Following treatment, even if he has undergone a successful vasectomy -to refrain from donating semen or sperm for at least 28 days after study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 30 days mortality after macroscopically complete resection ( R0 / R1 ) of pancreatic adenocarcinoma in combination with HIPEC;Secondary Objective: Safety and side effect profile ( CTCAE 4.0 );Primary end point(s): 30 days mortality after macroscopically complete resection ( R0 / R1 ) of pancreatic adenocarcinoma in combination with HIPEC;Timepoint(s) of evaluation of this end point: 30 days after macroscopically complete resection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and side effect profile ( CTCAE 4.0 );Timepoint(s) of evaluation of this end point: 30 days after macroscopically complete resection | — |
Countries
Germany
Contacts
Public ContactPI, Dr. med. P. Horvath
University Department of General, Visceral and Transplant Surgery Tübingen
Outcome results
None listed