Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Mortality
Time Frame: In-hospital or 90 days after surgery
Measurement of postoperative mortality will be recorded
Morbidity
Time Frame: In-hospital or 90 days after surgery
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
Secondary Outcomes
- Quality of Life after the Procedure(12 months post-surgery)
- Recurrence-Free Survival(12 months from surgery)
- Overall Survival(12 months from surgery)
Investigators
Tiago Bouça-Machado
MD
Unidade Local de Saúde São João