Safety Study Of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy For Adenocarcinoma

Study Overview

Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma

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.

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 unknown.

Pancreatic Neoplasms

DRUG: Gemcitabine/Gemzar
PROCEDURE: Laparoscopic Distal pancreatectomy

NA_00031399

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-05
First Submitted that Met QC Criteria 2010-01-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-06
First Posted (ESTIMATED) 2010-01-11	Results First Posted N/A	Last Verified 2016-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Patients with distal pancreatic cancer Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy	DRUG: Gemcitabine/Gemzar Six cycles of Gemcitabine will be given. Each cycle of Gemcitabine comprises of Gemcitabine 1000 mg/m2 as a 30 minute infusion once weekly for 3 weeks with a fourth week off. PROCEDURE: Laparoscopic Distal pancreatectomy Laparoscopic resection of the distal pancreas

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Patients with distal pancreatic cancer

Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy

DRUG: Gemcitabine/Gemzar

Six cycles of Gemcitabine will be given. Each cycle of Gemcitabine comprises of Gemcitabine 1000 mg/m2 as a 30 minute infusion once weekly for 3 weeks with a fourth week off.

PROCEDURE: Laparoscopic Distal pancreatectomy

Laparoscopic resection of the distal pancreas

Primary Outcome Measures	Measure Description	Time Frame
To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy.		1 year

Secondary Outcome Measures	Measure Description	Time Frame
To determine the if the 1-year survival in patients with pancreatic cancer is improved with administration of gemcitabine one week following laparoscopic distal pancreatectomy		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma

Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Martin A Makary, MD, MPH, Johns Hopkins University Department of Surgery

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Crane CH, Abbruzzese JL, Evans DB, Wolff RA, Ballo MT, Delclos M, Milas L, Mason K, Charnsangavej C, Pisters PW, Lee JE, Lenzi R, Vauthey JN, Wong AB, Phan T, Nguyen Q, Janjan NA. Is the therapeutic index better with gemcitabine-based chemoradiation than with 5-fluorouracil-based chemoradiation in locally advanced pancreatic cancer? Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1293-302. doi: 10.1016/s0360-3016(01)02740-7.
Kachnic LA, Shaw JE, Manning MA, Lauve AD, Neifeld JP. Gemcitabine following radiotherapy with concurrent 5-fluorouracil for nonmetastatic adenocarcinoma of the pancreas. Int J Cancer. 2001 Apr 20;96(2):132-9. doi: 10.1002/ijc.1008.
Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. doi: 10.1001/jama.299.9.1019.

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