S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
- Conditions
- Esophageal Cancer
- Interventions
- Registration Number
- NCT00086996
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo Plus RT, Surgery, Chemo fluorouracil neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo oxaliplatin neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo conventional surgery neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin Chemo Plus RT, Surgery, Chemo radiation therapy neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
- Primary Outcome Measures
Name Time Method Pathological Complete Response 10-16 weeks after beginning study treatment 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
Name Time Method Overall Survival 0-5 years Measured from time of registration to death, or last contact date
Progression-free Survival 0-3 years 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.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Up to 3 years Only adverse events that are possibly, probably or definitely related to study drug are reported.
Trial Locations
- Locations (143)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Highland General Hospital
🇺🇸Oakland, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
St. John's Regional Medical Center
🇺🇸Joplin, Missouri, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Tom K Lee, Incorporated
🇺🇸Oakland, California, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Highlands Oncology Group - Springdale
🇺🇸Bentonville, Arkansas, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸Pleasanton, California, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Gape Girardeau, Missouri, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Frontier Cancer Center
🇺🇸Great Falls, Montana, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Randolph Hospital
🇺🇸Asheboro, North Carolina, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Rockwood Clinic Cancer Treatment Center
🇺🇸Spokane, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Olathe Cancer Center
🇺🇸Olathe, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
🇺🇸Greensboro, North Carolina, United States
Annie Penn Cancer Center
🇺🇸Reidsville, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States