Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
NCT ID: NCT00470184
Last Updated: 2013-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.
Detailed Description
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Primary
* Determine the complete pathologic response (complete response \[CR\]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, and radiotherapy.
Secondary
* Determine the clinical efficacy and toxicity of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.
* Identify basal expression and changes in gene expression that relate to CR, relapse, and survival of patients treated with this regimen.
OUTLINE:
* Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on the same days they undergo radiotherapy.
* Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who are eligible undergo esophagectomy.
* Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene expression studies, microarray analysis, and real-time quantitative reverse transcriptase-PCR to identify basal expression and changes in gene expression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemo
Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy
capecitabine
Oral
oxaliplatin
IV
gene expression analysis
Correlative Study
microarray analysis
Correlative Study
reverse transcriptase-polymerase chain reaction
Correlative Study
adjuvant therapy
Metastatic growth control
biopsy
Examination of tissue type
conventional surgery
Tissue removal
neoadjuvant therapy
Tumor shrinkage
quality-of-life assessment
Correlative Study
radiation therapy
Undergoing radiation therapy
Interventions
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capecitabine
Oral
oxaliplatin
IV
gene expression analysis
Correlative Study
microarray analysis
Correlative Study
reverse transcriptase-polymerase chain reaction
Correlative Study
adjuvant therapy
Metastatic growth control
biopsy
Examination of tissue type
conventional surgery
Tissue removal
neoadjuvant therapy
Tumor shrinkage
quality-of-life assessment
Correlative Study
radiation therapy
Undergoing radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
* Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
* Bulk of gastroesophageal junction tumor should be in the esophagus
* Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors
* No known brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy \> 4 months
* WBC \> 4,000/mm³
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9 g/dL
* Bilirubin normal
* Creatinine normal
* AST \< 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Able to take oral medication or undergo enteral administration of medication
* No peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 90 days after completion of study treatment
* No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
* No concurrent uncontrolled illness, including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would preclude study compliance
* No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* Other cured tumors allowed at discretion of the principal investigator
* No known HIV or hepatitis B or C (active and/or previously treated)
PRIOR CONCURRENT THERAPY:
* No prior therapy for esophageal cancer
* No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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National Comprehensive Cancer Network
NETWORK
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Nikhil Khushalani, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-I-64105
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000543376
Identifier Type: -
Identifier Source: org_study_id