Trial of pancreas carcinoma patients pancreas with chemotherapy located within the peritoneal cavityafter pancreatic surgery
- Conditions
- 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.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002288-41-DE
- Lead Sponsor
- niversity Department of General, Visceral and Transplant Surgery Tuebingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
= 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
• 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 <60 ml / min.).
• patients where the intra-operative frozen section no adenocarcinoma of the pancreas can be demonstrated
• Patients suffering from a second malignancy (within 5 years in the study of consent) except basal cell carcinoma and curative treated in-situ carcinoma of the cervix
• distant metastases (M> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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