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

Alternate Title

Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Basic Trial Information

Objectives

Primary

1. Assess and compare the pathologic complete response rate of sequential docetaxel, oxaliplatin, and capecitabine followed by fluorouracil, oxaliplatin, and radiotherapy versus fluorouracil, oxaliplatin, and radiotherapy alone in patients with potentially resectable advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia.

Secondary

1. Assess the adverse event profile and safety of these regimens in this patient population.
2. Assess and compare the overall survival of patients treated with these regimens.
3. Assess and compare the disease-free survival between treatment arms.
4. Assess and compare the clinical tumor response rate of these proposed regimens when administered before surgery between treatment arms.
5. Evaluate the profiles of pharmacogenetic and proteomic marker measures over time, and assess the association of changes in these biomarkers induced by these proposed regimens with pathologic tumor response and other outcomes of interest.
6. Evaluate the profiles of FDG PET/CT measures, including standardized uptake values and % injected dose in the tumor volume over time, and assess the correlation of changes in PET measures with pathologic tumor response and other outcomes of interest.

Entry Criteria

Disease Characteristics:

• Histologically confirmed locally advanced adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia
  • Surgically resectable disease
    • T4N0M0 tumors that are potentially resectable allowed
    • T1N0M0 or T2N0M0 tumors not allowed

• Nodal involvement:
  • Involvement of celiac nodes (stations 15-20) allowed if the primary lesion is mid-thoracic, distal esophagus, or GE junction
  • Supraclavicular node involvement allowed with upper thoracic-esophagus primary lesions
  • No palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction

• No evidence of distant metastases

Prior/Concurrent Therapy:

• No prior radiotherapy to ≥ 30% of the marrow cavity
• No prior or other concurrent treatment for this malignancy
• No concurrent intensity-modulated radiotherapy

Patient Characteristics:

• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 3 times ULN
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow pills
• Willing to return to NCCTG enrolling institution for follow-up
• Willing to provide mandatory tissue and blood samples for research purposes
• Willing to undergo FDG PET/CT scans for mandatory research purposes
• No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Not immunocompromised unless related to the use of corticosteroids
  • No known HIV positivity
• No uncontrolled intercurrent illness including, but not limited to, the following conditions:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness and/or social situations that would limit compliance with study requirements
• No uncontrolled diabetes
• No other active malignancy, except for non-melanoma skin cancer or carcinoma in-situ of the cervix, unless curatively treated with no evidence of disease within the past 5 years and not on concurrent specific treatment for cancer other than hormonal therapy

Expected Enrollment

Outcomes

Pathologic complete response rate

Overall survival
Disease-free survival
Adverse events
Clinical tumor response (complete and partial response)
Pharmacogenetic and proteomic marker measures
PET measure profiles including standardized uptake values and %-injected dose of tumor volume

Outline

This is a multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), and disease stage (II vs III/IVA). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive fluorouracil* IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery.

• Arm II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery as in arm I.*

   [Note: * Fluorouracil continuous IV infusion begins within 24 hours of radiotherapy and ends within 24 hours of radiotherapy completion.]

   [Note: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of docetaxel, oxaliplatin, and capecitabine.]

Blood samples are collected at baseline and periodically during study for pharmacogenetic (genetic polymorphisms along with drug target pathways) and proteomic markers (microRNA and mRNA expression) studies. Tumor tissue samples from biopsy and surgery are also collected for pharmacogenetic and proteomic markers studies and future correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-4918

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Colorado
	Fort Collins
	Front Range Cancer Specialists
		Robert Marschke, Jr.	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Bloomington
	St. Joseph Medical Center
		Nguyet Le-Lindqwister	Ph:  309-662-3311
	Bloomington%
	Illinois CancerCare - Bloomington
		Nguyet Le-Lindqwister	Ph:  309-662-2102
	Canton
	Graham Hospital
		Nguyet Le-Lindqwister	Ph:  309-647-5240
	Illinois CancerCare - Canton
		Nguyet Le-Lindqwister	Ph:  309-647-5240
	Carthage
	Illinois CancerCare - Carthage
		Nguyet Le-Lindqwister	Ph:  217-357-6877
	Eureka
	Eureka Community Hospital
		Nguyet Le-Lindqwister	Ph:  309-467-2371
	Illinois CancerCare - Eureka
		Nguyet Le-Lindqwister	Ph:  309-467-2371
	Galesburg
	Galesburg Clinic, PC
		Nguyet Le-Lindqwister	Ph:  309-344-1000
	Illinois CancerCare - Galesburg
		Nguyet Le-Lindqwister	Ph:  309-344-9269
	Havana
	Illinois CancerCare - Havana
		Nguyet Le-Lindqwister	Ph:  309-543-8557
	Mason District Hospital
		Nguyet Le-Lindqwister	Ph:  309-543-4431
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet Le-Lindqwister	Ph:  309-852-0598
	Macomb
	Illinois CancerCare - Macomb
		Nguyet Le-Lindqwister	Ph:  309-833-3503
	McDonough District Hospital
		Nguyet Le-Lindqwister	Ph:  309-833-4101
	Moline
		Costas Constantinou, MD	Ph:  563-359-9876
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  563-359-9876
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet Le-Lindqwister	Ph:  309-734-3141
	OSF Holy Family Medical Center
		Nguyet Le-Lindqwister	Ph:  309-734-3141
	Normal
	BroMenn Regional Medical Center
		Nguyet Le-Lindqwister	Ph:  309-454-1400
	Community Cancer Center
		Nguyet Le-Lindqwister	Ph:  309-451-8500
	Illinois CancerCare - Community Cancer Center
		Nguyet Le-Lindqwister	Ph:  309-662-2102
	Ottawa
	Community Hospital of Ottawa
		Nguyet Le-Lindqwister	Ph:  815-433-3100
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		Nguyet Le-Lindqwister	Ph:  815-431-9270
	Pekin
	Cancer Treatment Center at Pekin Hospital
		Nguyet Le-Lindqwister	Ph:  309-353-0512
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet Le-Lindqwister	Ph:  309-243-3605 800-793-2262
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		Nguyet Le-Lindqwister	Ph:  309-243-3000
	OSF St. Francis Medical Center
		Nguyet Le-Lindqwister	Ph:  309-655-2000
	Proctor Hospital
		Nguyet Le-Lindqwister	Ph:  309-691-1000
	Peru
	Illinois CancerCare - Peru
		Nguyet Le-Lindqwister	Ph:  815-780-3185
	Illinois Valley Community Hospital
		Nguyet Le-Lindqwister	Ph:  815-223-3000
	Princeton
	Illinois CancerCare - Princeton
		Nguyet Le-Lindqwister	Ph:  815-875-3010
	Perry Memorial Hospital
		Nguyet Le-Lindqwister	Ph:  815-875-2811
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
Iowa
	Bettendorf
		Costas Constantinou, MD	Ph:  563-359-9876
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
	Mercy Cancer Center - West Lakes
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	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
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
	West Des Moines
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Methodist West Hospital
		Robert Behrens	Ph:  515-343-1000
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert Padula	Ph:  616-966-8000
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Gilbert Padula	Ph:  616-391-2799
	CCOP - Grand Rapids
		Gilbert Padula	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Gilbert Padula	Ph:  616-752-5222
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Iron Mountain
	Dickinson County Healthcare System
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Monroe
	Community Cancer Center of Monroe
		Rex Mowat	Ph:  734-242-7902
	Mercy Memorial Hospital - Monroe
		Rex Mowat	Ph:  734-240-8400
	Muskegon
	Mercy General Health Partners
		Gilbert Padula	Ph:  231-672-2000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Reed City
	Spectrum Health Reed City Hospital
		Gilbert Padula	Ph:  231-832-3271
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Traverse City
	Munson Medical Center
		Gilbert Padula	Ph:  231-935-6202
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Daniel Anderson	Ph:  952-892-2000
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Daniel Anderson	Ph:  763-236-6000
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Daniel Anderson	Ph:  763-236-5000
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minnesota Oncology - Maplewood
		Daniel Anderson	Ph:  651-779-7978
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Daniel Anderson	Ph:  952-993-1517
	Park Nicollet Cancer Center
		Daniel Anderson	Ph:  952-993-3248
	Saint Paul
	United Hospital
		Daniel Anderson	Ph:  651-241-8000
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Daniel Anderson	Ph:  952-403-2031
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Stillwater
	Lakeview Hospital
		Daniel Anderson	Ph:  651-439-5330 800-423-7212
	Waconia
	Ridgeview Medical Center
		Daniel Anderson	Ph:  952-442-2191 800-967-4620
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Daniel Anderson	Ph:  320-231-4650 800-247-1478
	Woodbury
	Minnesota Oncology - Woodbury
		Daniel Anderson	Ph:  651-735-7414
Missouri
	Bolivar
	Central Care Cancer Center at Carrie J. Babb Cancer Center
		Robert Carolla	Ph:  417-326-7200 800-592-5110
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Benjamin Marchello, MD	Ph:  406-238-6290
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
North Carolina
	Rutherfordton
	Rutherford Hospital
		James Bearden, MD	Ph:  864-560-6812
North Dakota
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Bowling Green
	Wood County Oncology Center
		Rex Mowat	Ph:  419-352-9498
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Elyria
	Community Cancer Center
		Rex Mowat	Ph:  440-324-0400
	Hematology Oncology Center
		Rex Mowat	Ph:  440-324-0401
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lima
	Lima Memorial Hospital
		Rex Mowat	Ph:  419-228-3335
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Maumee
	Northwest Ohio Oncology Center
		Rex Mowat	Ph:  419-891-5600
		Rex Mowat	Ph:  419-891-5600
	Mount Vernon
	Knox Community Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Norwalk
	Fisher-Titus Medical Center
		Rex Mowat	Ph:  419-668-8101 800-589-3862
	Oregon
	St. Charles Mercy Hospital
		Rex Mowat	Ph:  419-696-7200
	Toledo Clinic - Oregon
		Rex Mowat	Ph:  419-691-4235
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Rex Mowat	Ph:  419-447-3130
	Toledo
	CCOP - Toledo Community Hospital
		Rex Mowat	Ph:  419-843-6147
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Rex Mowat	Ph:  419-407-2663
	St. Vincent Mercy Medical Center
		Rex Mowat	Ph:  419-251-4515
	Toledo Clinic, Incorporated - Main Clinic
		Rex Mowat	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
South Carolina
	Anderson
	AnMed Cancer Center
		Clinical Trials Office - AnMed Cancer Center	Ph:  864-512-1000
	Greenville
	Bon Secours St. Francis Health System
		Clinical Trails Office - Bon Secours St. Francis Health System	Ph:  864-255-1713
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
South Dakota
	Sioux Falls
	Avera Cancer Institute
		Addison Tolentino	Ph:  605-322-3000
		Addison Tolentino	Ph:  605-322-3000
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Rex Mowat	Ph:  540-368-0500
Wisconsin
	Eau Claire
	Luther Midlelfort Hospital
		Daniel Burns, MD	Ph:  715-838-6072
	Midelfort Clinic - Luther
		Clinical Trials Office - Midelfort Clinic - Luther	Ph:  715-838-6072
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center	Ph:  920-320-2749
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Sheboygan
	St. Nicholas Hospital
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Sturgeon Bay
	Door County Cancer Center at Door County Memorial Hospital
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited - Sturgeon Bay
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
Official Title		Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
Trial Start Date		2010-02-02
Trial Completion Date		2012-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00938470
Date Submitted to PDQ		2009-06-25
Information Last Verified		2012-05-18
NCI Grant/Contract Number		CA25524

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