Clinical trial NCT02863471: Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma
Official 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Adenocarcinomas of the Pancreas
Keywords: Pancreas
Adenocarcinoma
Hyperthermic intraperitoneal chemotherapy
HIPEC
Pancreatic surgery
Gemcitabine
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Despite medical progress in recent years in pancreatic reach the 5-year survival rates even after radical surgical resection only 20%, which is due to high rates of local recurrence and distant metastases in the postoperative course. Due to the anatomical position of the pancreas resections are having a "wide margin" technically almost impossible, so that the tumor on postoperative preparation is often marginal forming. A further possible explanation for the high number of local recurrences, intraoperative tumor cell displacement in question.

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). Purpose of HIPEC it is to kill any remaining microscopic residual tumor or residual tumor cells free. The aim of the present phase I / II study is therefore to examine the importance of HIPEC in addition to radical resection of ductal pancreatic cancer in terms of mortality and morbidity.

Eligibility criteria: 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.

Primary outcomes:
measure: 30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC)
timeFrame: day 30
Secondary outcomes:
measure: Nausea
timeFrame: day 30
measure: Vomiting
timeFrame: day 30
measure: Diarrhea
timeFrame: day 30
measure: Stomatitis
timeFrame: day 30
measure: Hair loss
timeFrame: day 30
measure: Neutrophilia
timeFrame: day 30
measure: Thrombocytopenia
timeFrame: day 30
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital
state: Baden-Württemberg
Study officials:
affiliation: University Department of General, Visceral and TransplantSurgery Tuebingen
name: Stefan Beckert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yurttas C, Horvath P, Fischer I, Meisner C, Nadalin S, Konigsrainer I, Konigsrainer A, Beckert S, Loffler MW. A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Dec;28(13):9086-9095. doi: 10.1245/s10434-021-10187-8. Epub 2021 Jun 15.