Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
OBJECTIVES:
Primary
- Assess and compare the pathologic complete response rate of sequential docetaxel,
oxaliplatin, and capecitabine followed by fluorouracil, oxaliplatin, and radiotherapy
versus fluorouracil, oxaliplatin, and radiotherapy alone in patients with potentially
resectable advanced adenocarcinoma of the esophagus, gastroesophageal junction, or
gastric cardia.
Secondary
- Assess the adverse event profile and safety of these regimens in this patient
population.
- Assess and compare the overall survival of patients treated with these regimens.
- Assess and compare the disease-free survival between treatment arms.
- Assess and compare the clinical tumor response rate of these proposed regimens when
administered before surgery between treatment arms.
- Evaluate the profiles of pharmacogenetic and proteomic marker measures over time, and
assess the association of changes in these biomarkers induced by these proposed
regimens with pathologic tumor response and other outcomes of interest.
- Evaluate the profiles of FDG PET/CT measures, including standardized uptake values and
% injected dose in the tumor volume over time, and assess the correlation of changes in
PET measures with pathologic tumor response and other outcomes of interest.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0-1 vs 2), and disease stage (II vs III/IVA). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day
1. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable
toxicity. After completion of the second course, patients receive fluorouracil* IV
continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of
disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion
of radiotherapy, patients undergo surgery.
- Arm II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV
over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery
as in arm I.* NOTE: * Fluorouracil continuous IV infusion begins within 24 hours of
radiotherapy and ends within 24 hours of radiotherapy completion.
NOTE: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of
docetaxel, oxaliplatin, and capecitabine.
Blood samples are collected at baseline and periodically during study for pharmacogenetic
(genetic polymorphisms along with drug target pathways) and proteomic markers (microRNA and
mRNA expression) studies. Tumor tissue samples from biopsy and surgery are also collected
for pharmacogenetic and proteomic markers studies and future correlative studies.
After completion of study therapy, patients are followed up every 3-6 months for 2 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response rate
No
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000646724
NCT00938470
February 2010
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
Hinsdale, Illinois 60521 | |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Wesley Medical Center | Wichita, Kansas 67214 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Dakota Cancer Institute at Dakota Clinic - South University | Fargo, North Dakota 58103-4940 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Bettendorf, Iowa 52722 | |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Midelfort Clinic - Luther | Eau Claire, Wisconsin 54702 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Galesburg | Galesburg, Illinois 61401 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Luther Midlelfort Hospital | Eau Claire, Wisconsin 54702 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |
Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar, Missouri 65613 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |