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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02644 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000407534 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity.
Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment.
Patients are followed every 3 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gefitinib | Experimental | Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gefitinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year overall survival rate | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time | Up to 5 years | |
| Disease-free survival | Up to 5 years | |
| Time to disease recurrence |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Locally advanced disease
T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement
Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months
No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No prior gefitinib
No concurrent CYP3A4 inducing agents, including any of the following:
No concurrent antacids 4 hours before or after study drug administration
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36251211 | Derived | Smith RS, Foster NR, Jatoi A, Thome SD, Miller RC. Incidence of Brain Metastasis as First Event in Patients with Esophageal Carcinoma: a Report from Three Prospective Alliance Clinical Trials. J Gastrointest Cancer. 2023 Sep;54(3):846-854. doi: 10.1007/s12029-022-00871-7. Epub 2022 Oct 17. |
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| Up to 5 years |
| Time to treatment failure | Up to 5 years |
| Quality of life | Up to 5 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Kewanee Hospital | Kewanee | Illinois | 61443 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | 47374 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center | Des Moines | Iowa | 50316-2301 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa | 50266 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Meeker County Memorial Hospital | Lichfield | Minnesota | 55355 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Broadway | Fargo | North Dakota | 58122 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Fremont Memorial Hospital | Fremont | Ohio | 43420 | United States |
| Kenton Oncology, Incorporated | Kenton | Ohio | 43326 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537 | United States |
| St. Luke's Hospital | Maumee | Ohio | 43537 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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