Esophageal Cancer Clinical Trial

S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

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Full Description

OBJECTIVES:

Primary

Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.

Secondary

Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients.
Determine the overall survival and progression-free survival of patients treated with this regimen.

Exploratory Analyses (subject to funding availability)

Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine (γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum (XPA) with response and survival of patients treated with this regimen.
Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and after treatment with this regimen with survival of these patients.
Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.
Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy.
Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction

No recurrent disease
Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
Esophageal disease confined to esophagus and peri-esophageal soft tissue
Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

Clinical stage II or III disease by CT scan or MRI

If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
Positron-emission tomography scan is required to confirm stage
Measurable or non-measurable disease by x-ray, scanning, or physical examination

No celiac axis nodes ≥ 1.5 cm

Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
White blood cell (WBC) count ≥ 3,000/mm^3
Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

Albumin ≥ 3 g/dL
Bilirubin normal

Renal

Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

No active pneumonia or inflammatory lung infiltrate

Other

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
No peripheral neuropathy ≥ grade 2
Not pregnant or nursing
Fertile patients must use effective contraception

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

Surgery

No prior surgical resection or attempted surgical resection of esophageal cancer

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT00086996

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 113 Locations for this study

See Locations Near You

Mobile Infirmary Medical Center
Mobile Alabama, 36652, United States
Providence Cancer Center
Anchorage Alaska, 99508, United States
Highlands Oncology Group - Springdale
Bentonville Arkansas, 72712, United States
East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Eden Medical Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants - Castro Valley
Castro Valley California, 94546, United States
Valley Medical Oncology
Fremont California, 94538, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Breast Surgeons, Incorporated
Oakland California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland California, 94609, United States
Tom K Lee, Incorporated
Oakland California, 94609, United States
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs California, 92262, United States
Valley Care Medical Center
Pleasanton California, 94588, United States
Valley Medical Oncology Consultants - Pleasanton
Pleasanton California, 94588, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Doctors Medical Center - San Pablo Campus
San Pablo California, 94806, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton Illinois, 62002, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
Mt. Vernon Illinois, 62864, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Reid Hospital & Health Care Services
Richmond Indiana, 47374, 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
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, 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
Olathe Cancer Center
Olathe Kansas, 66061, 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
Cotton-O'Neil Cancer Center
Topeka Kansas, 66606, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, 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
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
Boston University Cancer Research Center
Boston Massachusetts, 02118, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Metro Health Hospital
Grand Rapids Michigan, 49506, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Hackley Hospital
Muskegon Michigan, 49442, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau Missouri, 63701, United States
St. John's Regional Medical Center
Joplin Missouri, 64804, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Frontier Cancer Center
Great Falls Montana, 59405, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown New York, 10940, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Mission Hospitals - Memorial Campus
Asheville North Carolina, 28801, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro North Carolina, 27403, United States
Annie Penn Cancer Center
Reidsville North Carolina, 27320, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, 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
Middletown Regional Hospital
Franklin Ohio, 45005, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Clinton Memorial Hospital
Wilmington Ohio, 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport Tennessee, 37662, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
American Fork Hospital
American Fork Utah, 84003, United States
Sandra L. Maxwell Cancer Center
Cedar City Utah, 84720, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
LDS Hospital
Salt Lake City Utah, 84103, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
Norton Virginia, 24273, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Columbia Basin Hematology
Kennewick Washington, 99336, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Rockwood Clinic Cancer Treatment Center
Spokane Washington, 99204, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT00086996

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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