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 |
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.
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.
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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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Tri M. Le
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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
Falls Church, Virginia 22042
(703) 776-4001
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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
Kalamazoo, Michigan 49007
(269) 382-2500
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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
Portland, Oregon 97213
(503) 215-1111
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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
Rochester, New York 14642
(585) 275-2121
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Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222
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Phone: 800-804-8824
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
(605) 322-4700
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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
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Ann Arbor, Michigan 48109
800-865-1125
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5301 McAuley Drive
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Ann Arbor, Michigan 48197
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
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Battle Creek, Michigan 49017
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
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Boston, Massachusetts 02118
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
(573) 519-4725
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Chapel Hill, North Carolina 27599
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Phone: 877-668-0683
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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Phone: 800-804-9376
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Charlotte, North Carolina 28277
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
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University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
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Cincinnati, Ohio 45219
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1 Hospital Dr
Columbia, Missouri 65212
Columbia, Missouri 65212
(573) 882-2100
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University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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Columbus, Ohio 43210
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Commack, New York 11725
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Dallas, Texas 75390
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Phone: 214-590-5582
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1200 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-6212
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Phone: 515-239-2621
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
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Phone: 313-916-3721
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
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
Durham, North Carolina 27710
919-684-8111
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Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Evanston, Illinois 60201
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Fairfax, Virginia 22031
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8505 Arlington Boulevard
Fairfax, Virginia 22031
Fairfax, Virginia 22031
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801 Broadway North
Fargo, North Dakota 58122
Fargo, North Dakota 58122
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Phone: 701-323-5760
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Fargo, North Dakota 58122
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39400 Paseo Padre Parkway
Fremont, California 94538
Fremont, California 94538
(510) 248-3000
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Kaiser Permanente - Fremont You can rely on Kaiser Permanente for quality care, delivered with...
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Geneva, Illinois 60134
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Goshen, Indiana 46526
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
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Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
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Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Kansas City, Kansas 66160
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
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Lexington, Kentucky
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1983 Marengo St
Los Angeles, California 90033
Los Angeles, California 90033
(323) 226-2622
Principal Investigator: Syma Iqbal
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Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
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U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Louisville, Kentucky 40202
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
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Miami, Florida 33136
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Middletown, New Jersey 07748
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1660 Springhill Avenue
Mobile, Alabama 36604
Mobile, Alabama 36604
(251) 665-8000
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6701 Airport Boulevard
Mobile, Alabama 36607
Mobile, Alabama 36607
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3719 Dauphin Street
Mobile, Alabama 36608
Mobile, Alabama 36608
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225 Summit Avenue
Montvale, New Jersey 07645
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New Brunswick, New Jersey 08903
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New Brunswick, New Jersey 08903
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New Orleans, Louisiana 70121
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Eileen M. O'Reilly
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New York, New York 10032
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
Newark, Delaware 19718
302-733-1000
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Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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Oakland, California 94611
Principal Investigator: Tatjana Kolevska
Phone: 510-891-3400
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Orange, California 92868
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Orlando, Florida 32803
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Pembroke Pines, Florida 33028
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Petoskey, Michigan 49770
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Philadelphia, Pennsylvania 19111
Principal Investigator: Sanjay Reddy
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3401 N Broad St
Philadelphia, Pennsylvania
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
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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Redwood City, California 94063
Principal Investigator: Tatjana Kolevska
Phone: 510-891-3400
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