Phase II Study of Adjuvant Gemcitabine Started One Week After Laparoscopic
Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or
metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been
investigated in clinical trials, but the overall conclusions are that these agents have
failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis
make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six
weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the
patient is waiting to begin therapy. This leads to the increased incidence of locoregional
recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for
cancer allows quicker recovery and significantly reduces the chances of postoperative wound
breakdown. This will shorten the wait time required to begin adjuvant therapy to one week
after surgery thereby combating the micrometastasis unseen at the time of surgery.
Prognosis for patients with pancreatic cancer will therefore improve along with decreasing
the incidence of locoregional recurrence.
Methods: We will perform a prospective, non-randomized phase II study with patients
undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins
Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week
following laparoscopic distal pancreatectomy according to the protocol designed by our
medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed
in the medical oncology clinic weekly. Our Primary outcome variable will be all cause
postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase
II study. Early termination rules include development of prohibitive toxicity or death.
Our endpoints are an improvement in overall survival, quality of life, progression free
survival, or disease free survival. Exclusion criteria will include patients with T4 or M1
disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy.
Martin A Makary, MD, MPH
Johns Hopkins University Department of Surgery
United States: Food and Drug Administration
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