Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:December 2016
Contact:Matthew Katz, MD, FACS
Phone:713-794-4660

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Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with
or without hypofractionated radiation therapy before surgery works in patients with
pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy,
such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy
delivers higher doses of radiation therapy over a shorter period of time and may kill more
tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is
more effective with or without hypofractionated radiation therapy before surgery in treating
patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. To evaluate and estimate 18 months overall survival (OS) rate of patients with borderline
resectable pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant therapy.

SECONDARY OBJECTIVES:

I. To evaluate and estimate the R0 resection rates in patients receiving each of the two
multimodality treatment regimens.

II. To evaluate and estimate the event-free survival in patients receiving each of the two
multimodality treatment regimens.

III. To evaluate and estimate the pathologic compete response (pCR) rates in patients
receiving each of the two multimodality treatment regimens.

IV. To assess the adverse events (AE) profile and safety of each treatment arm.

TERTIARY OBJECTIVES:

I. To test the effect of the rs2853564 vitamin D receptor (VDR) variant on OS rate and
discover novel candidate genes associated with OS and severe toxicity of chemotherapy by
using genome-wide genotyping approaches.

II. To evaluate risk classification previously developed by Koay et al using normalized area
under the enhancement curve (NAUC).

III. To access prognostic value of NAUC ratio defined as post-neoadjuvant NAUC divided by
pre-neoadjuvant therapy NAUC.

IV. To evaluate risk classification previously developed by Koay et al using delta measure.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan IV over 90
minutes, and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil
IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days for 8 courses
in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan IV over 90
minutes, and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil
IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days for 7 courses
in the absence of disease progression or unacceptable toxicity. Patients receive either
stereotactic body radiation therapy (SBRT) or hypofractionated image guided radiation therapy
(HIGRT) on days 1-5 of course 8.

SURGERY Within 4 to 8 weeks after the last dose of chemotherapy (arm A) or of radiation (arm
B), patients considered surgical candidates for resection (after central review) will undergo
surgery at the registering institution.

ADJUVANT CHEMOTHERAPY Within 4-12 weeks from the date of surgery, patients will receive
oxaliplatin IV over 2 hours and leucovorin IV over 2 hours on day 1. Patients also receive
fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days
for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 16 weeks for 2 years,
then every 6 months for 5 years.

Inclusion Criteria:

- Confirmation of radiographic stage as borderline resectable disease by real-time
Alliance central radiographic review

- No prior chemotherapy or radiation for pancreatic cancer

- No definitive resection of pancreatic cancer

- Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3,
subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on
strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration
on the study

- Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients
must discontinue the drug 14 days prior to the start of study treatment

- No grade >= 2 neuropathy

- No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism

- No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days
of registration

- Not pregnant and not nursing; for women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required

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

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Creatinine =< 1.5 x upper limit of normal (ULN) or

- Calculated (calc.) creatinine clearance > 45 mL/min

- Total bilirubin =< 2.0 mg/dL

- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit
of normal (ULN)
We found this trial at
142
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
Principal Investigator: Puja Nistala
Phone: 573-882-7440
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Itzhak Nir
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Tri M. Le
Phone: 434-243-6322
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Timothy L. Cannon
Phone: 703-208-6650
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul M. Barr
Phone: 585-275-5830
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Andrew L. Coveler
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Principal Investigator: Mark R. Huber
Phone: 888-634-7268
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Allentown, Pennsylvania 18103
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Phone: 734-712-3671
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Antioch, California 94531
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Jin He
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265 Fremont St
Battle Creek, Michigan 49017
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450 Brookline Ave
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617-632-3000
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789 Mt Auburn Rd
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171 Ashley Avenue
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Charlotte, North Carolina 28277
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5841 S Maryland Ave
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Commack, New York 11725
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
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Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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8505 Arlington Boulevard
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801 Broadway North
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39400 Paseo Padre Parkway
Fremont, California 94538
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Greenville, South Carolina 29615
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500 Westchester Avenue
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500 University Dr
Hershey, Pennsylvania 17033
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Huntington, West Virginia 25701
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535 Barnhill Dr
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3855 Health Sciences Dr,
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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1983 Marengo St
Los Angeles, California 90033
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1441 Eastlake Ave
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600 Highland Ave
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2160 South 1st Avenue
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1660 Springhill Avenue
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Petoskey, Michigan 49770
Principal Investigator: Anteneh A. Tesfaye
Phone: 800-248-6777
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Philadelphia, Pennsylvania 19111
Principal Investigator: Sanjay Reddy
Phone: 215-728-4790
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Sanjay Reddy
Phone: 215-728-2983
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: James A. Posey
Phone: 215-955-6084
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Plainfield, Illinois 60585
Principal Investigator: Alexander Hantel
Phone: 630-646-6075
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Portland, Oregon 97225
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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Portland, OR
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Redwood City, California 94063
Principal Investigator: Tatjana Kolevska
Phone: 510-891-3400
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Reno, Nevada 89502
Principal Investigator: Christos A. Galanopoulos
Phone: 702-384-0013
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