Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:May 2013
End Date:June 15, 2018

Use our guide to learn which trials are right for you!

Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study

This pilot clinical trial studies combination chemotherapy and radiation therapy before
surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer.
Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin
calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination
chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the
amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill
any tumor cells that remain after surgery.

The purpose of this study is to evaluate a new treatment program for patients with borderline
resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and
chemoradiation have on your cancer and to see if it allows safe surgery.

Primary Objectives:

- To assess the accrual rate of this study.

- To assess the rate of treatment-related toxicity and treatment delay during preoperative
therapy.

- To assess the rate of completion of all preoperative and operative therapy.

Secondary Objectives:

- To assess the macroscopic (R0/R1) resection rate.

- To estimate the rate of radiographic and histopathologic response to preoperative
therapy.

- To estimate the time to locoregional and distant recurrence.

- To assess overall survival (OS).

- To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies
and to assess the quality of these nucleic acids using a sequencing-based assessment of
tumor DNA.

Pre-Registration Eligibility Criteria

- Documentation of Disease and Radiographic Staging

- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or
uncinate process

- Objective radiographic staging with a) contrast-enhanced, helical thin-cut
computed tomography (CT)/magnetic resonance imaging (MRI) scan of the abdomen and
b) CT scan/MRI of the chest

- Note: echoendoscopic staging will be permitted as an adjunctive modality, but all
stage definitions below will be determined using CT/MRI as outlined below. In the
event echoendoscopic stage and CT/MRI stage are discordant, the CT/MRI stage will
be used. Significant discordance should be discussed with the study principal
investigator (PI) prior to enrollment

- Borderline resectable primary tumor, defined by the presence of any one or more
of the following on CT/MRI, and confirmed by central radiographic review:

- An interface between the primary tumor and the superior mesenteric vein or
portal vein (SMV-PV) measuring ≥ 180 degrees of the circumference of the
vessel wall

- Short-segment occlusion of the SMV-PV with normal vein above and below the
level of obstruction that is amenable to resection and venous reconstruction

- Short segment interface (of any degree) between tumor and hepatic artery
with normal artery proximal and distal to the interface that is amenable to
resection and reconstruction

- An interface between the tumor and superior mesenteric artery (SMA)
measuring < 180 degrees of the circumference of the vessel wall

- No potentially resectable disease defined as primary tumors with all of the
following:

- An interface between the primary tumor and the superior mesenteric vein or
portal vein (SMV-PV) measuring < 180 degrees of the circumference of the
vessel wall

- No radiographic interface between the tumor and the (superior mesenteric
artery) SMA, hepatic artery or celiac axis

- No radiographic evidence of metastatic disease

- No metastatic disease defined as any one or more of the following:

- Suspicious lymphadenopathy outside the standard surgical field (i.e.,
aortocaval nodes, distant abdominal nodes)

- Radiographic evidence for metastatic disease in distant organs, such as
masses in distant organs or ascites

- No locally advanced and/or unresectable disease clearly defined by any one or
more of the following by CT/MRI:

- An interface between the tumor and the SMA measuring ≥ 180 degrees of the
circumference of the vessel wall

- No interface between the tumor and the aorta

- Occlusion of the SMV or portal vein without a sufficient cuff of normal vein
above and below the level of obstruction with which to perform venous
reconstruction

- Long-segment interface (of any degree) between the tumor and the common
hepatic artery or its major tributaries with insufficient artery proximal
and distal to the interface to perform reconstruction

- No prior chemotherapy or chemoradiation for pancreatic cancer

- No patients with a "currently active" second malignancy other than non-melanoma skin
cancers. Patients are not considered to have a "currently active" malignancy if they
have completed therapy and are free of disease for ≥ 3 years

- Baseline peripheral sensory neuropathy must be grade < 2

- No patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism

- No history of pulmonary embolism in the past 6 months

- Age ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0-1

- Pregnancy/Nursing Status: Non-pregnant and non-breast-feeding. Female participants of
child-bearing potential must have a negative urine or serum pregnancy test prior to
registration. Perimenopausal participants must be amenorrheic > 12 months to be
considered not of childbearing potential.

- Required Pre-Registration Laboratory Values:

- Granulocytes ≥ 2,000/ul

- Hemoglobin > 9 g/dL

- Platelets ≥ 100,000/ul

- Albumin > 3.0 g/dL

- Creatinine ≤1.5 x upper limit of normal (ULN)

Registration Eligibility Criteria

- Confirmation of pre-registration eligibility criteria as described under
"Documentation of Disease and Radiographic Staging" by the Alliance Central
Radiographic Review

- Required Registration Laboratory Values:

- Bilirubin ≤2 mg/dl

- AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN
We found this trial at
14
sites
401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
West Chester, Ohio 45069
?
mi
from
West Chester, OH
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials