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

Alternate Title

Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

Basic Trial Information

Objectives

Primary

1. To determine whether trastuzumab increases disease-free survival when combined with radiotherapy, paclitaxel, and carboplatin followed by surgery in patients with HER2-overexpressing esophageal adenocarcinoma.

Secondary

1. To evaluate whether the addition of trastuzumab to this neoadjuvant chemoradiation increases the pathologic complete response rate and overall survival of these patients.
2. To develop a tissue bank of tumor tissue from patients with non-metastatic esophageal adenocarcinoma.
3. To determine molecular correlates of complete pathologic response, disease-free survival, and overall survival of patients treated with these regimens.
4. To evaluate predictors of cardiotoxicity in patients treated with these regimens.
5. To evaluate adverse events associated with these regimens in these patients.

Tertiary

1. To determine whether trastuzumab improves patient-reported Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E), Esophageal Cancer Subscale (ECS) score.
2. To determine whether an improvement in the FACT-E ECS score at 6-8 weeks after completion of neoadjuvant chemoradiation correlates with pathologic complete response.
3. To determine whether pathologic complete response correlates with the FACT-E ECS score at 1 year and/or 2 years in patients treated with these regimens.
4. To determine whether the addition of trastuzumab to neoadjuvant chemoradiation improves the Swallow Index and Eating Index Subscale scores of the FACT-E of these patients.
5. To determine whether the addition of trastuzumab to neoadjuvant chemoradiation impacts quality-adjusted survival of these patients.

Entry Criteria

Disease Characteristics:

• Pathologically confirmed primary adenocarcinoma of the esophagus meeting the following criteria:
  • Involvement of mid (up to 25 cm), distal, or esophagogastric junction
    • Involvement of the stomach up to 5 cm allowed
    • Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
  • Stage T1, N1-2 or T2-3, N0-2 disease by chest, abdominal, or pelvic CT scan or whole-body PET/CT scan
    • No T1,N0 or T4 disease
    • No metastatic disease
  • Regional adenopathy including para-esophageal, gastric, gastrohepatic, and celiac (≤ 2 cm) nodes allowed
  • No cervical esophageal or proximal esophageal (15-24 cm) carcinoma

• Must have undergone endoscopy with biopsy

• HER2-overexpressing adenocarcinoma of the esophagus

• Disease must be encompassed in 1 radiotherapy field

• Able to undergo curative resection within 56 days after completion of chemoradiation

• No evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior systemic chemotherapy for esophageal cancer
  • Prior chemotherapy for a different cancer allowed
• No prior radiotherapy for esophageal cancer or prior chest radiotherapy
• No prior anthracycline or taxane
• No prior therapy with any agent targeting the HER2 pathway or HER1 (EGFR) pathway
• No prior trastuzumab
• No other concurrent radiotherapy
• No other concurrent investigational agents
• No other concurrent cytotoxic agents

Patient Characteristics:

• Zubrod performance status 0-2
• ANC ≥ 1,500 cells/mm³
• Platelet count ≥ 100,000 cells/mm³
• Hemoglobin (Hb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hb ≥ 8.0 g/dL allowed)
• Creatinine ≤ 2 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST ≤ 3.0 times ULN
• LVEF normal
• Negative pregnancy test
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for ≥ 60 days after completion of chemotherapy or trastuzumab
• No prior invasive malignancy except nonmelanomatous skin cancer or curatively treated carcinoma in situ of the breast, oral cavity, or cervix with no evidence of disease within the past 2 years
• No medical contraindications to esophagectomy
• No prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody
• No history of congestive heart failure
• No severe or active comorbidity defined as any of the following:
  • Unstable angina within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics
  • AIDS or immunocompromised patients
    • HIV testing is not required

Expected Enrollment

Outcomes

Disease-free survival

Pathologic complete response
Overall survival
Adverse events
Health-related quality of life as measured by FACT-E
Quality-adjusted survival
Molecular correlates of efficacy
Predictors of cardiotoxicity

Outline

This is a multicenter study. Patients are stratified according to presence of adenopathy (yes vs no), and involved celiac nodes (absent vs presence ≤ 2 cm). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy (may include intensity-modulated radiotherapy [IMRT]) once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57.

• Arm II: Patients undergo radiotherapy (may include IMRT) once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36.

Within 5-6 weeks after completion of radiotherapy, all patients undergo surgery. Beginning 21-56 days after surgery, all patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and tumor tissue samples collection (during surgery) for correlative studies and tissue bank.

Patients may complete the Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) and the EuroQol (EQ-5D) questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up every 4 months for 2 years and then yearly thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Howard Safran, MD, Principal investigator		Ph: 401-793-7151

U.S.A.
Alabama
	Mobile
	Providence Cancer Center at Providence Hospital
		Robert Gilbert	Ph:  251-633-1890
California
	Chico
	Enloe Cancer Center at Enloe Medical Center
		Clinical Trials Office - Enloe Cancer Center at Enloe Medical Center	Ph:  530-332-3808
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	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
	Sacramento
	South Sacramento Cancer Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	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
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Fort Collins
	Poudre Valley Radiation Oncology
		Joshua Petit	Ph:  970-482-3328
	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
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Swati Dutta	Ph:  860-714-4680
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
	Norwich
	William W. Backus Hospital
		Dennis Slater, MD	Ph:  860-886-8362
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Florida
	Stuart
	Robert and Carol Weissman Cancer Center at Martin Memorial
		Kiran Reddy	Ph:  772-288-5858
Georgia
	Atlanta
	Piedmont Hospital
		Adam Nowlan	Ph:  404-605-5000 866-605-5111
	Fayetteville
	Piedmont Fayette Hospital
		Adam Nowlan	Ph:  770-719-7000
	Macon
	Medical Center of Central Georgia
		Frederick Schnell, MD, FACP	Ph:  478-743-7068
	Savannah
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		John Pablo	Ph:  912-819-6000
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
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-4750
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Oak Lawn
	Advocate Christ Medical Center
		Amar Hamad	Ph:  708-684-8000
Indiana
	Muncie
	Cancer Center at Ball Memorial Hospital
		Clinical Trials Office - Cancer Center at Ball Memorial Hospital	Ph:  765-281-2107
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Cedar Rapids
	Mercy Regional Cancer Center at Mercy Medical Center
		Deborah Wilbur	Ph:  319-398-6011
	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
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Prairie Village
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  913-948-5588
Kentucky
	Lexington
	Central Baptist Hospital
		Clinical Trials Office - Central Baptist Hospital	Ph:  859-260-6425
	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
Maine
	Scarborough
	Maine Center for Cancer Medicine and Blood Disorders - Scarborough
		Ian Bristol	Ph:  207-885-7600
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Cancer Center	Ph:  443-849-3706
	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
Massachusetts
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Seth Kaufman	Ph:  413-794-9338
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
	Saint Joseph Mercy Cancer Center
		Swati Dutta	Ph:  734-712-5658 888-474-4673
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	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
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Warren
	St. John Macomb Hospital
		Swati Dutta	Ph:  586-573-5757 888-593-2237
Minnesota
	Maplewood
	Minnesota Oncology - Maplewood
		Paul Sperduto, MD, MAPP	Ph:  952-442-6000
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
Missouri
	Cape Girardeau
	Cancer Institute of Cape Girardeau, LLC
		Tapan Roy, MD	Ph:  573-334-2230
	Saint Louis
	Barnes-Jewish West County Hospital
		Clifford Robinson	Ph:  314-996-8000
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Clifford Robinson	Ph:  314-747-7222 800-600-3606
	Saint Peters
	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
		Clifford Robinson	Ph:  636-916-9920
	Springfield
	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
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew Huang	Ph:  402-354-5890 877-850-3212
Nevada
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Daniel Weed	Ph:  775-982-5050 866-559-0558
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Voichita Bar Ad	Ph:  973-726-4180
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	New York
	Beth Israel Medical Center - Petrie Division
		Clinical Trials Office - Beth Israel Medical Center - Petrie Division	Ph:  212-844-6286
	St. Luke's - Roosevelt Hospital Center - St.Luke's Division
		Peter Kozuch, MD	Ph:  212-523-6769
	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
North Carolina
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Concord
	Batte Cancer Center at Northeast Medical Center
		Jonathan Salo	Ph:  704-783-1322 800-575-1275
	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
North Dakota
	Minot
	Trinity CancerCare Center
		Kevin Collins, MD	Ph:  701-857-3535
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
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Dayton
	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
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Mentor
	Lake/University Ireland Cancer Center
		Min Yao	Ph:  440-205-5755
	Orange Village
	UHHS Chagrin Highlands Medical Center
		Min Yao	Ph:  216-292-1783
	Oregon
	St. Charles Mercy Hospital
		Rex Mowat	Ph:  419-696-7200
	Ravenna
	Robinson Radiation Oncology
		Mitchell Fromm, MD	Ph:  330-344-6448
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Toledo
	St. Anne Mercy Hospital
		Rex Mowat	Ph:  419-407-2663
	Westlake
	UHHS Westlake Medical Center
		Min Yao	Ph:  440-250-2001
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Terence Herman	Ph:  405-271-6822
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Matthew Solhjem	Ph:  503-513-3300
	Portland
	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
Pennsylvania
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Dunmore
	Northeast Radiation Oncology Center
		Voichita Bar Ad	Ph:  570-504-7200 888-808-6762
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Pittsburgh
	UPMC - Shadyside
		Clinical Trials Office - UPMC - Shadyside	Ph:  412-621-2334
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
Rhode Island
	Providence
	Northmain Radiation Oncology
		Howard Safran, MD	Ph:  401-793-7151
	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 - Eastside
		Clinical Trials Office - Cancer Centers of the Carolinas	Ph:  864-241-6251
	Cancer Centers of the Carolinas - Faris Road
		David Grisell	Ph:  864-679-3900
	CCOP - Greenville
		David Grisell	Ph:  864-241-6251
	Greer
	Cancer Centers of the Carolinas - Greer Radiation Oncology
		David Grisell	Ph:  864-334-4900
	Seneca
	Cancer Centers of the Carolinas - Seneca
		David Grisell	Ph:  864-888-3717
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		David Grisell	Ph:  864-699-5700
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
Utah
	Salt Lake City
	Utah Cancer Specialists at UCS Cancer Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
Washington
	Bellingham
	St. Joseph Cancer Center
		Michael Taylor, MD	Ph:  360-715-4144
	Seattle
	University Cancer Center at University of Washington Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	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
	Eau Claire
	Center for Cancer Treatment & Prevention at Sacred Heart Hospital
		Elena Theodosiou	Ph:  715-839-3956 800-839-3956
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Gregory Cooley, MD	Ph:  414-433-8184
	Marshfield
	Saint Joseph's Hospital
		Elena Theodosiou	Ph:  715-387-1713
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Veterans Affairs Medical Center - Milwaukee
		Elizabeth Gore, MD	Ph:  414-805-4369
	Minocqua
	Marshfield Clinic - Lakeland Center
		Elena Theodosiou	Ph:  715-358-1000 800-347-0673
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Elena Theodosiou	Ph:  715-236-8100
	Stevens Point
	Saint Michael's Hospital Cancer Center
		Elena Theodosiou	Ph:  715-346-5000 800-472-9449
	Weston
	Diagnostic and Treatment Center
		Elena Theodosiou	Ph:  715-393-3900

Registry Information
Official Title		A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
Trial Start Date		2010-07-01
Trial Completion Date		2014-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT01196390
Date Submitted to PDQ		2010-08-28
Information Last Verified		2012-05-25
NCI Grant/Contract Number		CA-21661

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