A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemotherapy With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas
The purpose of this phase II clinical trial study is to assess the resection rate among
subjects who have been initially diagnosed with unresectable or borderline resectable
pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will
include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this
clinical trial will assess the safety of preoperative chemotherapy with radiation therapy
for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic
head, assess margin-negative resection rates, disease-free survival, assess overall survival
rates, and determine patterns of local and distant recurrence.
The study population in this clinical trial will consist of untreated subjects 18 years or
older who have a histologically or cytologically confirmed diagnosis of unresectable or
borderline resectable adenocarcinoma of the pancreatic head. Once the patient has undergone
the necessary tests and the tumor has been staged, the principal investigator or
co-investigators will determine if the patient is suitable to be inducted in this clinical
trial. The course of preoperative treatment in this study will consist of an alternating
combination of 6mg/M² of Gemzar for 24 hours and 7.0 Gy of radiation therapy. The subject
will undergo one of these therapies alternating daily for a total of 10 days then the
subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After
surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6
cycles of 1000mg/M² of Gemzar over a 30 minute infusion rate.
The primary outcome of this clinical trial is the margin-negative resection rate. This will
be determined by the tumor's response to the pre/post-operative treatment so that the tumor
can be removed surgically via pancreaticoduodenectomy. Once the subject has completed the
treatment as described in the protocol, he/she will continued to be followed to assess
survival and patterns of local and distance recurrence. The purpose of this clinical trial
will be an attempt to provide subjects with a more hopeful alternative to treatment for a
disease that otherwise offers a grim prognosis.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival, disease-free survival,and recurrence
An average of 6 years
No
Issam Makhoul, MD
Principal Investigator
University of Arkansas
United States: Food and Drug Administration
112748
NCT01240304
November 2010
November 2016
Name | Location |
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University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |