Status:
COMPLETED
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Lead Sponsor:
Northwestern University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ra...
Detailed Description
OBJECTIVES: Primary * Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- Stage I-IVA disease
- No distant metastatic disease (other than regional lymph nodes)
- No evidence of CNS metastases
- CNS metastases stable for \> 3 months allowed
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Consuming ≥ 1,500 calories daily
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing neuropathy
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No known hypersensitivity to fluorouracil
- No known DPD deficiency
- No known hypersensitivity to any of the components of oxaliplatin
- No significant active infection or other severe complicated medical illness
- No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
- No myocardial infarction within the past 12 months
- No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- No malabsorption syndrome
- No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior participation in any investigational drug study
- No prior pelvic or thoracic radiotherapy
Exclusion
Key Trial Info
Start Date :
May 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00711412
Start Date
May 31 2006
End Date
January 30 2013
Last Update
July 18 2018
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013