Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery

Basic Trial Information

Special Category: CTSU trial

Objectives

Primary

1. To determine whether the addition of erlotinib hydrochloride to adjuvant chemotherapy comprising gemcitabine hydrochloride improves survival as compared to gemcitabine hydrochloride alone following R0 or R1 resection in patients with pancreatic adenocarcinoma.
2. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival of patients who have no evidence of progressive disease after 5 courses of gemcitabine hydrochloride-based chemotherapy.

Secondary

1. To evaluate the disease-free survival of patients who are disease-free after 5 courses of adjuvant gemcitabine hydrochloride-based chemotherapy followed by fluoropyrimidine-based chemoradiotherapy.
2. To evaluate the disease-free survival of patients treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride.
3. To evaluate the disease-free and overall survival of patients stratified by wild-type and K-Ras status treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride.
4. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without erlotinib hydrochloride in these patients.
5. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs without fluoropyrimidine-based chemoradiotherapy in patients who are disease-free after adjuvant gemcitabine hydrochloride-based chemotherapy.
6. To evaluate preoperative cross-sectional imaging of primary adenocarcinoma of the head of the pancreas in order to determine the frequency with which objective criteria of resectability are present.
7. To determine the predictive roles of K-Ras mutations and epithelial to mesenchymal transition phenotype in response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibition in early-stage pancreatic cancer.
8. To determine the frequency of EGFR-activated pathway and its influence on outcome.
9. To determine the association between developmental molecular markers and outcome.
10. To determine the phenotype and genotype of tumors in patients with recurrence after resection.
11. To determine if low baseline fatigue, as measured by the FACIT-Fatigue, predicts survival.
12. To explore correlations between baseline fatigue, as measured by PROMIS, and survival.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process
  • Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed
  • No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma

• Pathologic stage T1-3, N0-1, M0 disease according to AJCC 6th edition

• Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days
  • Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved
  • Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate])

• Post-resection serum CA19-9 ≤ 180 IU/L

• Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies

• No recurrent pancreatic cancer

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior systemic chemotherapy for pancreatic cancer
  • Prior chemotherapy for a different cancer allowed
• No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• Concurrent highly active antiretroviral treatment (HAART) allowed

Patient Characteristics:

• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
• Serum total bilirubin ≤ 2 times upper limit of normal (ULN)
• Creatinine ≤ 2 times ULN
• SGOT ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Suitable to receive study radiotherapy, as documented by a radiation oncologist
• Active HIV infection allowed provided the CD4 count is ≥ 499/mm³ and the viral load is ≤ 50 copies/mL
• Total oral caloric intake ≥ 1,500 calories/day
• No significant nausea and vomiting
• None of the following severe active comorbidities that would preclude study therapy:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 3 months
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
• No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ

Expected Enrollment

Outcomes

Overall survival of patients treated with gemcitabine hydrochloride with vs without erlotinib hydrochloride (first randomization)
Overall survival of patients treated with chemotherapy with vs without radiotherapy (second randomization)

Disease-free survival
Adverse events
Frequency of objective criteria of resectability as measured by preoperative imaging
Quality of life as measured by fatigue (FACIT-Fatigue and PROMIS-derived short form)
Laboratory correlative studies related to K-Ras in patients treated with gemcitabine hydrochloride with vs without erlotinib hydrochloride (first randomization)

Outline

This is a multicenter study. Patients are stratified according to nodal status (involved vs uninvolved), CA19-9 result (≤ 90 IU/L vs 91-180 IU/L), and surgical margins (positive [R1] vs negative [R0]). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive gemcitabine hydrochloride as in arm I and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.

Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV).

• Arm III: Patients receive 1 course of the same treatment that they receive in arm I or II.

• Arm IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5½ weeks (28 fractions). During radiotherapy, patients receive either oral capecitabine twice daily 5 days per week or fluorouracil IV continuously for 5½ weeks or until radiotherapy is completed.

Patients complete a quality-of-life questionnaires (FACIT-Fatigue and PROMIS) at baseline, after completion of treatment in arm I or II, and at 9, 12, and 24 months.

Tumor tissue and peripheral blood samples are collected for biomarker and other correlative laboratory studies. Urine samples may also be collected and studied in the laboratory.

After completion of study treatment, patients are followed up periodically.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Ross Abrams, MD, Protocol chair		Ph: 312-942-5771 Email: ross_a_abrams@rush.edu

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
California
	Auburn
	Auburn Radiation Oncology
		Christopher Jones, MD	Ph:  916-646-6600
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Christopher Jones, MD	Ph:  916-646-6600
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones, MD	Ph:  916-646-6600
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Fresno
	California Cancer Center - Woodward Park Office
		Brent Kane	Ph:  559-447-4050
	Saint Agnes Cancer Center at Saint Agnes Medical Center
		Clinical Trials Office - Saint Agnes Cancer Center	Ph:  559-450-7790
			Email: medresearch@samc.com
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Oakland
	Kaiser Permanente - Division of Research - Oakland
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Rancho Cordova
	Kaiser Permanente Medical Center - Rancho Cordova
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Rohnert Park
	Rohnert Park Cancer Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Roseville
	Kaiser Permanente Medical Center - Roseville
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Radiation Oncology Center - Roseville
		Christopher Jones, MD	Ph:  916-646-6600
	Sacramento
	Mercy General Hospital
		Christopher Jones, MD	Ph:  916-646-6600
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones, MD	Ph:  916-646-6600
	South Sacramento Cancer Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	San Diego
	Sharp Memorial Hospital Cancer Center
		Clinical Trials Office - Sharp Memorial Hospital Cancer Center	Ph:  858-939-5015
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-1591
	Santa Clara
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	South San Francisco
	Kaiser Permanente Medical Center - South San Francisco
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Vacaville
	Solano Radiation Oncology Center
		Christopher Jones, MD	Ph:  916-646-6600
Colorado
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Connecticut
	Bridgeport
	St. Vincent's Medical Center
		Stuart Marcus	Ph:  203-576-6000
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
District of Columbia
	Washington
	Washington Cancer Institute at Washington Hospital Center
		Clinical Trials Office - Washington Cancer Institute	Ph:  202-877-8839
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	M.D. Anderson Cancer Center at Orlando
		Daniel Buchholz	Ph:  407-648-3800 800-648-3818
	Panama City
	Bay Medical
		Hasan Murshed	Ph:  850-747-6972
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Frank Lake, MD	Ph:  770-535-3393
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		John Pablo	Ph:  912-819-6000
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979
	Hawaii Medical Center - East
		Jeffrey Berenberg, MD	Ph:  808-433-4089
	Queen's Cancer Institute at Queen's Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Stephen Smith	Ph:  208-381-2711 800-845-4624
Illinois
	Arlington Heights
	Northwest Community Hospital
		Stephen Nigh, MD	Ph:  847-618-6560
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	Rush University Medical Center
		Clinical Trials Office - Rush University Medical Center	Ph:  312-942-5498
			Email: clinical_trials@rush.edu
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-4673
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Naperville
	Edward Hospital Cancer Center
		Clinical Trials Office - Edward Hospital Cancer Center	Ph:  630-646-6075
	Springfield
	Cancer Institute at St. John's Hospital
		Cathy Clausen, MD	Ph:  765-646-8358
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Elkhart
	Elkhart General Hospital
		Robin Zon, MD	Ph:  574-296-6536
	Goshen
	Center for Cancer Care at Goshen General Hospital
		Clinical Trials Office - Center for Cancer Care at Goshen General Hospital	Ph:  574-535-2858
	South Bend
	CCOP - Northern Indiana CR Consortium
		Robin Zon, MD	Ph:  574-296-6536
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Des Moines
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
	New Orleans
	CCOP - Ochsner
		Troy Scroggins, MD	Ph:  504-842-3440
	Shreveport
	Feist-Weiller Cancer Center at Louisiana State University Health Sciences
		Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Ph:  318-813-1412
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	St. Agnes Hospital Cancer Center
		Richard Hudes, MD	Ph:  410-368-2965
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-638-8265
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Commerce
	Charach Cancer Center at Huron Valley - Sinai Hospital
		Andre Konski, MD	Ph:  215-728-2916
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Minnesota
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Paul Sperduto, MD, MAPP	Ph:  952-442-6000
	Maplewood
	Minnesota Oncology Hematology, PA - Maplewood
		Paul Sperduto, MD, MAPP	Ph:  952-442-6000
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Paul
	United Hospital
		Paul Sperduto, MD, MAPP	Ph:  952-442-6000
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
Missouri
	Saint Louis
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5514
	Springfield
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew Huang	Ph:  402-354-5890 877-850-3212
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Lawrence Dardick, MD	Ph:  775-982-5638
New Hampshire
	Manchester
	Elliot Regional Cancer Center at Elliot Hospital
		Brian Knab	Ph:  603-663-4201
New Jersey
	Basking Ridge
	Memorial Sloan-Kettering Cancer Center - Basking Ridge
		Karyn Goodman	Ph:  908-542-3000
	Livingston
	St. Barnabas Medical Center Cancer Center
		Clinical Trials Office - St. Barnabas Medical Center Cancer Center	Ph:  973-322-2470
	Ridgewood
	Valley Hospital - Ridgewood
		Thomas Rakowski, MD	Ph:  201-444-4526
New York
	Canandiaqua
	Sands Cancer Center
		Yuhchyau Chen	Ph:  585-396-6161 877-620-6161
	Commack
	Memorial Sloan-Kettering Cancer Center
		Karyn Goodman	Ph:  212-639-8895 800-525-2225
	Manhasset
	CCOP - North Shore University Hospital
		Beatrice Bloom	Ph:  516-734-8954
	New Hyde Park
	Long Island Jewish Medical Center
		Beatrice Bloom	Ph:  718-470-7000 800-371-7111
	New York
	Memorial Sloan-Kettering Cancer Center
		Karyn Goodman	Ph:  212-639-8895 800-525-2225
	Rochester
	Highland Hospital of Rochester
		Yuhchyau Chen	Ph:  585-473-2200
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Yuhchyau Chen	Ph:  585-275-5345
	University Radiation Oncology at Parkridge Hospital
		Yuhchyau Chen	Ph:  585-225-3989
	Rockville Centre
	Memorial Sloan-Kettering Cancer Center - Rockville Centre
		Karyn Goodman	Ph:  516-256-3651
North Carolina
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School	Ph:  252-744-2391
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Raleigh
	Rex Cancer Center at Rex Hospital
		Clinical Trials Office - Rex Cancer Center	Ph:  919-784-7209
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Mitchell Fromm, MD	Ph:  330-344-6448
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Barberton
	Barberton Citizens Hospital
		William Demas, MD	Ph:  330-375-3557
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Kevin Redmond, MD	Ph:  513-584-9089
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Zangmeister Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Elyria
	Community Cancer Center
		Rex Mowat	Ph:  440-324-0400
	Maumee
	Northwest Ohio Oncology Center
		Rex Mowat	Ph:  419-891-5600
	Salem
	Cancer Care Center, Incorporated
		William Demas, MD	Ph:  330-375-3557
	Sandusky
	North Coast Cancer Care, Incorporated
		Rex Mowat	Ph:  419-626-9090
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Wooster
	Cancer Treatment Center
		Clinical Trials Office - Cancer Treatment Center	Ph:  330-375-4221
Oklahoma
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Charles Stewart	Ph:  918-494-2273
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Matthew Solhjem	Ph:  503-513-3300
	Gresham
	Legacy Mount Hood Medical Center
		Clinical Trials Office - Legacy Mount Hood Medical Center	Ph:  503-413-2150
	Portland
	CCOP - Columbia River Oncology Program
		Matthew Solhjem	Ph:  503-216-6260
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Ph:  503-413-1742
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
	The Dalles
	Celilo Cancer Center at Mid-Columbia Medical Center
		Keith Stelzer, MD, PhD	Ph:  541-296-7204
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Easton
	Easton Regional Cancer Center at Easton Hospital
		Rajen Oza	Ph:  610-250-4567
	Gettysburg
	Adams Cancer Center
		Amit Shah	Ph:  717-741-8180
	Hanover
	Cherry Tree Cancer Center
		Amit Shah	Ph:  717-741-8180
	Philadelphia
	Albert Einstein Cancer Center
		Kenneth Zeitzer, MD	Ph:  215-456-6280
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
	York
	York Cancer Center at Apple Hill Medical Center
		Amit Shah	Ph:  717-741-8180
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		David Grisell	Ph:  864-679-3900
	CCOP - Greenville
		David Grisell	Ph:  864-241-6251
	Seneca
	Cancer Centers of the Carolinas - Seneca
		David Grisell	Ph:  864-888-3717
	Spartanburg
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Michael Swartz	Ph:  605-719-2360
Texas
	Amarillo
	Harrington Cancer Center
		Clinical Trials Officec - Harrington Cancer Center	Ph:  806-359-4673
			Email: ryokubaitis@harringtoncc.org
	Bedford
	Texas Oncology, PA at Harris Center HEB
		Vivek Kavadi	Ph:  817-359-9000
	Galveston
	University of Texas Medical Branch
		Clinical Trials Office - University of Texas Medical Branch	Ph:  409-772-1950
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	San Antonio
	Cancer Care Centers of South Texas - Northeast
		Vivek Kavadi	Ph:  210-656-7177
Utah
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		Clinical Trials Office - McKay-Dee Hospital Center	Ph:  801 387-7426
	Provo
	Utah Valley Regional Medical Center - Provo
		Clinical Trials Office - Utah Valley Regional Medical Center - Provo	Ph:  801-357-7965
	Saint George
	Dixie Regional Medical Center - East Campus
		Clinical Trials Office - Dixie Regional Medical Center - East Campus	Ph:  435-688-4167
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Clinical Trials Office - Huntsman Cancer Institute at University of Utah	Ph:  801-581-4477
			Email: clinical.trials@hci.utah.edu
	Utah Cancer Specialists at UCS Cancer Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
Virginia
	Norfolk
	Sentara Cancer Institute at Sentara Norfolk General Hospital
		Clinical Trials Office - Sentara Cancer Institute at Sentara Norfolk General Hospital	Ph:  757-388-2406
	Virginia Beach
	Coastal Cancer Center at Sentara Virginia Beach General Hospital
		Scott Williams	Ph:  757-395-8686
Washington
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Matthew Solhjem	Ph:  360-944-9889
	Southwest Washington Medical Center Cancer Center
		Matthew Solhjem	Ph:  360-514-2174
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Steven Jubelirer, MD	Ph:  304-388-8380
	Wheeling
	Schiffler Cancer Center at Wheeling Hospital
		Jon Pollock, MD	Ph:  304-243-3490
Wisconsin
	Antigo
	Langlade Memorial Hospital
		Darryl Barton, MD	Ph:  715-847-2866
	Green Bay
	Bellin Memorial Hospital
		Charlie Pan	Ph:  920-433-3500
	St. Mary's Hospital Medical Center - Green Bay
		Gregory Cooley, MD	Ph:  414-433-8184
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
Canada
Ontario
	London
	London Regional Cancer Program at London Health Sciences Centre
		Barbara Fisher	Ph:  519-685-8615
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Jason Pantarotto	Ph:  613-737-7700 ext. 70209 888-627-5346
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Marie-Pierre Campeau	Ph:  514-281-6000
	McGill Cancer Centre at McGill University
		Mohammad Niazi	Ph:  514-398-1444

Registry Information
Official Title		A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
Trial Start Date		2009-11-17
Trial Completion Date		2015-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT01013649
Date Submitted to PDQ		2009-11-06
Information Last Verified		2012-02-08
NCI Grant/Contract Number		CA21661

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