HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/20/2017 |
| Start Date: | February 2016 |
| End Date: | December 2016 |
Hyperthermic Intraperitoneal Chemotherapy as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma: A Prospective, Phase II, Proof-of-concept Study
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.
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.
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
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