Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer
Conditions
Keywords
Pancreatic Cancer, Cytoreduction Surgical Procedures, Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastasis, Peritoneal Carcinomatosis
Brief summary
The goal of this clinical trial is to evaluate the safety and feasibility of a combined surgical and chemotherapy approach (pancreatectomy with cytoreductive surgery and HIPEC) in patients aged 18 and older with pancreatic ductal adenocarcinoma and synchronous peritoneal metastases. The main questions it aims to answer are: Is the 90-day mortality rate for this intensive combined procedure lower than 5%? What are the postoperative morbidity and complication rates (as measured by the Clavien-Dindo classification) for these patients? How does this treatment impact the patient's quality of life 12 months after the procedure? Participants will: Complete at least 6 months of systemic chemotherapy to ensure the disease is stable or responding (biomarker CA19-9 must decline by \>20%). Undergo a major surgical procedure involving the removal of the pancreatic tumour (total Pancreatectomy or RAMPS) and any visible abdominal metastases (Cytoreductive Surgery). Receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), where heated Cisplatin and Paclitaxel are circulated in the abdominal cavity for 90 minutes during the operation. Participate in long-term follow-up to monitor recurrence-free and overall survival.
Interventions
PROCEDUREPancreatectomy
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
PROCEDUREComplete Cytoreduction
Resection of all macroscopic peritoneal metastases, but also the greater and lesser omentum, the round ligament of the liver, the appendix and the ovaries, in case of female patients
HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion
Sponsors
Unidade Local de Saúde São João
University Medical Center Hamburg-Eppendorf (UKE)
The Champalimaud Centre, Lisbon, Portugal
Leiden University Medical Center
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single-Arm, Open-Label, Multicentre Feasibility Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pancreatic adenocarcinoma * Histologically confirmed peritoneal metastasis * Excluded other sites of metastasis (except ovary) * PCI less than or equal to 6 * Age \> 18 years * ECOG performance status 0-1 * Written informed consent
Exclusion criteria
* Pregnancy * Intestinal obstruction * Renal insufficiency (GFR \< 45 ml/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | In-hospital or 90 days after surgery | Measurement of postoperative mortality will be recorded |
| Morbidity | In-hospital or 90 days after surgery | Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life after the Procedure | 12 months post-surgery | Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire |
| Recurrence-Free Survival | 12 months from surgery | Recurrence from surgery until cancer returns, or death from any cause |
| Overall Survival | 12 months from surgery | 12 months OS |
Countries
China, Portugal
Contacts
CONTACTTiago Bouça-Machado, MD
Outcome results
None listed