Clinical trial · Interventional
Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma
Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)
NCT02863471CI-TRIAL-00030131PanHIPECunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinomas of the Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine
- description
- 1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- 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
- description
- Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Secondary outcomes (7)
- measure
- Nausea
- timeFrame
- day 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYurttas 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. PMID 34131821