Clinical trial NCT02850874: HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma
Official title: Hyperthermic Intraperitoneal Chemotherapy as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma: A Prospective, Phase II, Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Pancreatic Adenocarcinoma
Keywords: hyperthermic intraperitoneal chemotherapy
perioperative systemic chemotherapy
peritoneal disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center, prospective proof-of-concept study is designed to evaluate the surgical outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT; neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk clinical features. The investigators hypothesize that HIPEC administered in this clinical course will reduce postoperative peritoneal disease recurrence. The investigators also expect that local recurrence of disease will be reduced. The primary aim of this study is to compare 2-year peritoneal disease-free survival between patients receiving the experimental therapy (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT + PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant HIPEC for resectable PDAC using patient demographics and disease characteristic data.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of pancreatic ductal adenocarcinoma (PDAC) confined to the head of the pancreas classified as T1-T3 with one or more of the following high-risk clinical features:

  * Carbohydrate antigen (CA) 19-9 greater than 1,000 U/mL with a normal bilirubin;
  * Vascular involvement; and/or
  * Suspicious regional lymphadenopathy
* Intention to undergo open pancreaticoduodenectomy (standard Whipple or pylorus-preserving pancreaticoduodenectomy) as treatment for PDAC
* Adequate clinical condition to undergo preoperative (neoadjuvant) hyperthermic intraperitoneal chemotherapy
* Adequate clinical condition to undergo perioperative systemic chemotherapy
* White blood cell count of at least 3000/mL
* Platelet count of at least 100,000/mL
* Normal creatinine (\< 2 mg/dL) or creatinine clearance of at least 50 mL/min
* Willing and able to give informed consent

Exclusion Criteria:

* Evidence of locoregional spread (carcinomatosis of peritoneal surfaces, mesenteric arteries, or body/tail of pancreas) or distant (liver, lung, or other) metastases (histological, CT, or MRI confirmation)
* Non-curative intent of treatment (≥R2 resection)
* Body mass index (BMI) \> 35
* Previous history of pancreatic resections for tumors in the body and/or tail of the pancreas, distal cholangiocarcinoma, duodenal carcinoma, neuroendocrine tumors, cyst-adenocarcinoma, or solid and papillary tumors.
* Unstable or uncompensated respiratory or cardiac disease
* Severe hepatic or renal dysfunction
* Bleeding diathesis or coagulopathy
* Pregnant or nursing women

Primary outcomes:
measure: Peritoneal disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 1, 2, 3, 5 years
measure: Local disease-free survival
timeFrame: 2 years
measure: Postoperative morbidity
timeFrame: 1 and 3 months
measure: Postoperative mortality
timeFrame: 1 and 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Dionisios Vrochides, MD PhD FACS
role: PRINCIPAL_INVESTIGATOR
References: