Status:
COMPLETED
Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 radi...
Detailed 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-fluor...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00938470
Start Date
January 1 2010
End Date
March 1 2018
Last Update
March 29 2018
Active Locations (187)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
3
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
4
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105