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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
oxaliplatin
conventional surgery
radiation therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mobile Infirmary Medical Center
  • Providence Cancer Center
  • Highlands Oncology Group - Springdale
  • East Bay Radiation Oncology Center
  • Eden Medical Center
  • Valley Medical Oncology Consultants - Castro Valley
  • Valley Medical Oncology
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Highland General Hospital
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Breast Surgeons, Incorporated
  • CCOP - Bay Area Tumor Institute
  • Larry G Strieff MD Medical Corporation
  • Tom K Lee, Incorporated
  • Desert Regional Medical Center Comprehensive Cancer Center
  • Valley Care Medical Center
  • Valley Medical Oncology Consultants - Pleasanton
  • University of California Davis Cancer Center
  • Doctors Medical Center - San Pablo Campus
  • Poudre Valley Hospital
  • Northeast Georgia Medical Center
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • Regional Cancer Center at Memorial Medical Center
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Reid Hospital & Health Care Services
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Cancer Center of Kansas, PA - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas, PA - Newton
  • Olathe Cancer Center
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Cotton-O'Neil Cancer Center
  • St. Francis Comprehensive Cancer Center
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Wesley Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Boston University Cancer Research Center
  • Battle Creek Health System Cancer Care Center
  • Mecosta County Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Butterworth Hospital at Spectrum Health
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Health Care
  • Metro Health Hospital
  • Holland Community Hospital
  • Hackley Hospital
  • Munson Medical Center
  • Saint Francis Medical Center
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  • St. John's Regional Medical Center
  • CCOP - Kansas City
  • CCOP - St. Louis-Cape Girardeau
  • David C. Pratt Cancer Center at St. John's Mercy
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare Cancer Care Services
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • St. James Healthcare Cancer Care
  • Big Sky Oncology
  • Frontier Cancer Center
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology at KRMC
  • Kalispell Regional Medical Center
  • Community Medical Center
  • Guardian Oncology and Center for Wellness
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Good Samaritan Cancer Center at Good Samaritan Hospital
  • Tucker Center for Cancer Care at Orange Regional Medical Center
  • Randolph Hospital
  • Mission Hospitals - Memorial Campus
  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  • Annie Penn Cancer Center
  • Rutherford Hospital
  • McDowell Cancer Center at Akron General Medical Center
  • Charles M. Barrett Cancer Center at University Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Charles F. Kettering Memorial Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Clinton Memorial Hospital
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • AnMed Cancer Center
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • CCOP - Scott and White Hospital
  • American Fork Hospital
  • Sandra L. Maxwell Cancer Center
  • Logan Regional Hospital
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • LDS Hospital
  • Utah Cancer Specialists at UCS Cancer Center
  • Southwest Virginia Regional Cancer Center at Wellmonth Health
  • St. Joseph Cancer Center
  • Olympic Hematology and Oncology
  • Columbia Basin Hematology
  • Fred Hutchinson Cancer Research Center
  • Harborview Medical Center
  • Minor and James Medical, PLLC
  • Veterans Affairs Medical Center - Seattle
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Polyclinic First Hill
  • University Cancer Center at University of Washington Medical Center
  • Cancer Care Northwest - Spokane South
  • Rockwood Clinic Cancer Treatment Center
  • Wenatchee Valley Medical Center
  • Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo Plus RT, Surgery, Chemo

Arm Description

neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin

Outcomes

Primary Outcome Measures

Pathological Complete Response
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.

Secondary Outcome Measures

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Overall Survival
Measured from time of registration to death, or last contact date
Progression-free Survival
measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.

Full Information

First Posted
July 8, 2004
Last Updated
September 4, 2013
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00086996
Brief Title
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
Official Title
Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemo Plus RT, Surgery, Chemo
Arm Type
Experimental
Arm Description
neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
eloxatin
Intervention Description
Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.
Primary Outcome Measure Information:
Title
Pathological Complete Response
Description
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
Time Frame
10-16 weeks after beginning study treatment
Secondary Outcome Measure Information:
Title
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame
Up to 3 years
Title
Overall Survival
Description
Measured from time of registration to death, or last contact date
Time Frame
0-5 years
Title
Progression-free Survival
Description
measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.
Time Frame
0-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence P. Leichman, MD
Organizational Affiliation
Desert Regional Medical Center Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles R. Thomas, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Providence Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Highlands Oncology Group - Springdale
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
East Bay Radiation Oncology Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Eden Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants - Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Highland General Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Breast Surgeons, Incorporated
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Larry G Strieff MD Medical Corporation
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Tom K Lee, Incorporated
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Desert Regional Medical Center Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Valley Care Medical Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Valley Medical Oncology Consultants - Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Doctors Medical Center - San Pablo Campus
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mt. Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Olathe Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cotton-O'Neil Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
St. Francis Comprehensive Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Mecosta County Medical Center
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Metro Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Holland Community Hospital
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Hackley Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49442
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
City
Gape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
St. John's Regional Medical Center
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Healthcare Cancer Care
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-5309
Country
United States
Facility Name
Frontier Cancer Center
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology at KRMC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
Good Samaritan Cancer Center at Good Samaritan Hospital
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68848-1990
Country
United States
Facility Name
Tucker Center for Cancer Care at Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940-4199
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203-5400
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403-1198
Country
United States
Facility Name
Annie Penn Cancer Center
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
AnMed Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Sandra L. Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Southwest Virginia Regional Cancer Center at Wellmonth Health
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Columbia Basin Hematology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
Polyclinic First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Rockwood Clinic Cancer Treatment Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2967
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Leichman L, Goldman BH, Benedetti JK, et al.: Oxaliplatin (OXP) plus protracted infusion 5-fluorouracil (PIFU) and external beam radiation (EBRT) prior to surgery (S) for potentially curable esophageal adenocarcinoma (EA): A Southwest Oncology Group (SWOG) phase II trial with molecular correlates (S0356). [Abstract] J Clin Oncol 27 (Suppl 15): A-4513, 2009.
Results Reference
result
PubMed Identifier
22025151
Citation
Leichman LP, Goldman BH, Bohanes PO, Lenz HJ, Thomas CR, Billingsley KG, Corless CL, Iqbal S, Gold PJ, Benedetti JK, Danenberg KD, Blanke CD. S0356: a phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and external-beam radiation therapy before surgery for patients with esophageal adenocarcinoma. J Clin Oncol. 2011 Dec 1;29(34):4555-60. doi: 10.1200/JCO.2011.36.7490. Epub 2011 Oct 24.
Results Reference
derived

Learn more about this trial

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

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