- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00109850
S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
- Determine the time to progression in patients with measurable disease treated with this regimen.
- Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)
OUTLINE: This is a multicenter study.
Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).
After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36652-2144
- Mobile Infirmary Medical Center
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Berkeley, California, États-Unis, 94704
- Alta Bates Comprehensive Cancer Center
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center - Burbank
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Burlingame, California, États-Unis, 94010
- Peninsula Medical Center
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Castro Valley, California, États-Unis, 94546
- Eden Medical Center
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Greenbrae, California, États-Unis, 94904
- Marin Cancer Institute at Marin General Hospital
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Greenbrae, California, États-Unis, 94904
- Sutter Health - Western Division Cancer Research Group
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Hayward, California, États-Unis, 94545
- Saint Rose Hospital
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Los Angeles, California, États-Unis, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Oakland, California, États-Unis, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, États-Unis, 94602
- Highland General Hospital
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Oakland, California, États-Unis, 94609
- CCOP - Bay Area Tumor Institute
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Palm Springs, California, États-Unis, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
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Pleasanton, California, États-Unis, 94588
- Valley Care Medical Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Cancer Center
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San Francisco, California, États-Unis, 94118
- California Pacific Medical Center - California Campus
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San Pablo, California, États-Unis, 94806
- Doctors Medical Center - San Pablo Campus
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Sana Rosa, California, États-Unis, 95405
- CCOP - Santa Rosa Memorial Hospital
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Vallejo, California, États-Unis, 94589
- Sutter Solano Medical Center
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Colorado
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Fort Collins, Colorado, États-Unis, 80524
- Poudre Valley Hospital
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Florida
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Lakeland, Florida, États-Unis, 33804-5000
- Watson Clinic, LLC
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Georgia
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Augusta, Georgia, États-Unis, 30901
- Augusta Oncology Associates - Walton Way
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Savannah, Georgia, États-Unis, 31403-3089
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Savannah, Georgia, États-Unis, 31405
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
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Idaho
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Boise, Idaho, États-Unis, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Springfield, Illinois, États-Unis, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Indiana
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Beech Grove, Indiana, États-Unis, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Richmond, Indiana, États-Unis, 47374
- Reid Hospital & Health Care Services, Incorporated
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Kansas
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kansas City, Kansas, États-Unis, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, États-Unis, 67901
- Southwest Medical Center
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, États-Unis, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, États-Unis, 67042
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, États-Unis, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, États-Unis, 67214
- Wesley Medical Center
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Wichita, Kansas, États-Unis, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, États-Unis, 67214
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, États-Unis, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Battle Creek, Michigan, États-Unis, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, États-Unis, 49307
- Mecosta County Medical Center
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Detroit, Michigan, États-Unis, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Grand Rapids, Michigan, États-Unis, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, États-Unis, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, États-Unis, 49506
- Metro Health Hospital
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Grand Rapids, Michigan, États-Unis, 49503
- Spectrum Health Hospital - Butterworth Campus
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Holland, Michigan, États-Unis, 49423
- Holland Community Hospital
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Muskegon, Michigan, États-Unis, 49442
- Hackley Hospital
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Traverse City, Michigan, États-Unis, 49684
- Munson Medical Center
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Missouri
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110
- Saint Louis University Cancer Center
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Springfield, Missouri, États-Unis, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, États-Unis, 65804
- St. John's Regional Health Center
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Springfield, Missouri, États-Unis, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, États-Unis, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, États-Unis, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, États-Unis, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, États-Unis, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, États-Unis, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, États-Unis, 59405
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Helena, Montana, États-Unis, 59601
- St. Peter's Hospital
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Kalispell, Montana, États-Unis, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, États-Unis, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, États-Unis, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, États-Unis, 59801
- Community Medical Center
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Missoula, Montana, États-Unis, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, États-Unis, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, États-Unis, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Kearney, Nebraska, États-Unis, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
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New York
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Rochester, New York, États-Unis, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Rochester, New York, États-Unis, 14623
- Interlakes Oncology/Hematology PC
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North Carolina
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Goldsboro, North Carolina, États-Unis, 27534
- Wayne Memorial Hospital, Incorporated
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Ohio
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Akron, Ohio, États-Unis, 44307
- McDowell Cancer Center at Akron General Medical Center
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Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
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Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital
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Dayton, Ohio, États-Unis, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, États-Unis, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, États-Unis, 45429
- CCOP - Dayton
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Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Medical Associates
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Kettering, Ohio, États-Unis, 45429
- Charles F. Kettering Memorial Hospital
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Middletown, Ohio, États-Unis, 45044
- Middletown Regional Hospital
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Troy, Ohio, États-Unis, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Xenia, Ohio, États-Unis, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oregon
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Gresham, Oregon, États-Unis, 97030
- Legacy Mount Hood Medical Center
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Milwaukie, Oregon, États-Unis, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, États-Unis, 97227
- Northwest Cancer Specialists at Rose Quarter Cancer Center
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Portland, Oregon, États-Unis, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, États-Unis, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, États-Unis, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, États-Unis, 97210
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
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Portland, Oregon, États-Unis, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, États-Unis, 97239-3098
- Oregon Health & Science University Cancer Institute
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Salem, Oregon, États-Unis, 97309-5014
- Salem Hospital Regional Cancer Care Services
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Tualatin, Oregon, États-Unis, 97062
- Legacy Meridian Park Hospital
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston, South Carolina, États-Unis, 29401
- Roper St. Francis Cancer Center at Roper Hospital
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Tennessee
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Kingsport, Tennessee, États-Unis, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Knoxville, Tennessee, États-Unis, 37920-6999
- U.T. Cancer Institute at University of Tennessee Medical Center
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Virginia
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Danville, Virginia, États-Unis, 24541
- Danville Regional Medical Center
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Norton, Virginia, États-Unis, 24273
- Southwest Virginia Regional Cancer Center
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Washington
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Bellingham, Washington, États-Unis, 98225
- St. Joseph Cancer Center
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Bremerton, Washington, États-Unis, 98310
- Olympic Hematology and Oncology
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Kennewick, Washington, États-Unis, 99336
- Columbia Basin Hematology
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Mt. Vernon, Washington, États-Unis, 98273
- Skagit Valley Hospital Cancer Care Center
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Seattle, Washington, États-Unis, 98104
- Harborview Medical Center
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Seattle, Washington, États-Unis, 98104
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, États-Unis, 98104
- Minor and James Medical, PLLC
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Seattle, Washington, États-Unis, 98112
- Group Health Central Hospital
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Seattle, Washington, États-Unis, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, États-Unis, 98122
- Polyclinic First Hill
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Seattle, Washington, États-Unis, 98195-6043
- University Cancer Center at University of Washington Medical Center
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Spokane, Washington, États-Unis, 99202
- Cancer Care Northwest - Spokane South
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Vancouver, Washington, États-Unis, 98684
- Northwest Cancer Specialists at Vancouver Cancer Center
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Vancouver, Washington, États-Unis, 98668
- Southwest Washington Medical Center Cancer Center
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Wenatchee, Washington, États-Unis, 98801-2028
- Wenatchee Valley Medical Center
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Wyoming
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Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
- Disease confined to the esophagus or peri-esophageal soft tissue
- T4, M0 disease
- Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease
NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks
- Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
- Tumor specimens available
- No recurrent disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- White Blood Cell (WBC) count ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
Hepatic
- Albumin normal
- Bilirubin normal
- Alkaline phosphatase normal
- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal
Renal
- Creatinine clearance > 50 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior severe reaction to monoclonal antibodies
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for esophageal cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for esophageal cancer
- No concurrent intensity modulated radiotherapy
- No concurrent cobalt-60
Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
|
400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only.
250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
Autres noms:
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Autres noms:
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Autres noms:
The total dose to the prescription point will be 5,040 cGy given in 28 fractions.
The patient will be treated with one fraction per day with all fields treated per day.
180 cGy will be delivered to the isocenter.
The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival at 2 Years
Délai: 0-2 years
|
Measured from time of registration to date of death due to any cause, or last contact date
|
0-2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Délai: Patients were assessed for adverse events after every two cycles of chemotherapy.
|
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
For each patient, worst grade of each event type is reported.
Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
|
Patients were assessed for adverse events after every two cycles of chemotherapy.
|
|
Objective Response (Confirmed and Unconfined, Complete and Partial)
Délai: at week 16, then every 3 months until progression
|
Complete response (CR) is complete disappearance of all measurable and non-measurable disease.
No new lesions.
No disease related symptoms.
Normalization of markers and other abnormal lab values.
Partial response (PR) applies only to patients with at least one measurable lesion.
Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
No unequivocal progression of non-measurable disease.
No new lesions.
Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
|
at week 16, then every 3 months until progression
|
|
Progression Free Survival
Délai: 0 - 5 years
|
Measured from date of registration to date of first observation of progression or symptomatic deterioration.
Patients last known to be alive and progression-free are censored at date of last contact.
|
0 - 5 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
- Chaise d'étude: Charles R. Thomas, MD, OHSU Knight Cancer Institute
- Chaise d'étude: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
- Chaise d'étude: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs de l'oesophage
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de la topoisomérase
- Agents antinéoplasiques immunologiques
- Inhibiteurs de la topoisomérase I
- Cisplatine
- Irinotécan
- Cétuximab
Autres numéros d'identification d'étude
- CDR0000426442
- U10CA032102 (Subvention/contrat des NIH des États-Unis)
- S0414 (Autre identifiant: SWOG)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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-
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-
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