Adenocarcinomas of the Pancreas Clinical Trial
— PanHIPECOfficial title:
Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).
| Status | Recruiting |
| Enrollment | 16 |
| Est. completion date | October 2018 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - = 18 years - Computertomographic (CT) morphologically suspected pancreatic tumor without distant metastases, with the possibility of a macroscopically complete resection residual tumor classification (R) R0 / R1 . - Histological diagnosis of adenocarcinoma of the pancreas' in the frozen section intraoperatively - Karnofsky Index > 70 Exclusion Criteria: - Patients who are considered inoperable because of reduced general - Congestive heart failure New York Heart Association (NYHA) III / IV - Severe coronary heart disease, non-treatable arrhythmia or nonadjustable hypertension, - Severe asthma suffering, chronic obstructive pulmonary disease (COPD) - Renal insufficiency (serum creatinine = 1.5 x of normal, or creatinine clearance <60 milliliter (ml) / minutes (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 insitu 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 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. - Pregnancy, 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital | Tübingen | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC) | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Nausea | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Vomiting | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Diarrhea | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Stomatitis | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Hair loss | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Neutrophilia | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | |
| Secondary | Thrombocytopenia | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 |