Esophageal Cancer Clinical Trial
Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Summary
This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Full Description
PRIMARY OBJECTIVES:
I. To assess and compare the pathologic complete response (PCR) rate of patients in Arm A receiving the sequence docetaxel, oxaliplatin, and capecitabine (DOC) followed by 5-fluorouracil (5-FU), oxaliplatin, and radiation therapy (RT) with patients in Arm B receiving only 5-FU, oxaliplatin and RT in patients with potentially resectable adenocarcinoma (ACA) of the esophagus, gastroesophageal junction (GEJ), or gastric cardia.
SECONDARY OBJECTIVES:
I. To assess the adverse event (AE) profile and safety of the proposed treatment in this population.
II. To assess and compare the overall survival (OS) between treatment arms. III. To assess and compare the disease-free survival between treatment arms. IV. To assess and compare the clinical tumor response rate of the proposed regiments when administered before surgery between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine orally (PO) twice daily (BID) 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.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Eligibility Criteria
Inclusion Criteria
Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia
Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that are potentially resectable are also eligible
Nodal involvement: patients with involvement of celiac nodes, (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction; patients with supraclavicular node involvement are eligible with upper thoracic esophagus primary lesions
Capable of swallowing pills
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Absolute neutrophil count (ANC) >= 1500
Peripheral platelet count >= 100,000
Hemoglobin >= 9.0 g/dL
Total bilirubin =< 1.5 x upper normal limit (UNL)
Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x UNL
Creatinine =< 1.5 x UNL
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Provide informed written consent
Willingness to return to NCCTG enrolling institution for follow-up
Patient willing to provide mandatory tissue and blood samples for research purposes
Patient willing to allow use of FDG PET/CT scans for mandatory research purposes
Exclusion Criteria
Evidence of distant metastases
Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic or GE junction
T1N0M0 or T2N0M0 tumor stage
Any of the following
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans)
Receiving current treatment or prior treatment for this malignancy
Other active malignancy 5 years prior to registration, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer
Prior radiation to > 30% of the marrow cavity
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There are 148 Locations for this study
Scottsdale Arizona, 85259, United States
Fort Collins Colorado, 80524, United States
Fort Collins Colorado, 80528, United States
Hartford Connecticut, 06105, United States
Jacksonville Florida, 32224, United States
Boise Idaho, 83706, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Havana Illinois, 62644, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Macomb Illinois, 61455, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Monmouth Illinois, 61462, United States
Monmouth Illinois, 61462, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Princeton Illinois, 61356, United States
Beech Grove Indiana, 46107, United States
Richmond Indiana, 47374, United States
Bettendorf Iowa, 52722, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Battle Creek Michigan, 49017, United States
Dearborn Michigan, 48123, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Muskegon Michigan, 49443, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Reed City Michigan, 49677, United States
Saginaw Michigan, 48601, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Bolivar Missouri, 65613, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Albuquerque New Mexico, 87131, United States
Rutherfordton North Carolina, 28139, United States
Fargo North Dakota, 58103, United States
Grand Forks North Dakota, 58201, United States
Chillicothe Ohio, 45601, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45420, United States
Delaware Ohio, 43015, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Greenville Ohio, 45331, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45505, United States
Troy Ohio, 45373, United States
Westerville Ohio, 43081, United States
Xenia Ohio, 45385, United States
Zanesville Ohio, 43701, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29601, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Eau Claire Wisconsin, 54703, United States
Eau Claire Wisconsin, 54703, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sheboygan Wisconsin, 53081, United States
Sturgeon Bay Wisconsin, 54235, United States
Sturgeon Bay Wisconsin, 54235, United States
Sheridan Wyoming, 82801, United States
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