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)
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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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