Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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.
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer|
- Complete Response [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
- Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1 [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
- Median Time to Progression [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
- Quality of Life Improved Rate [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
IVGenetic: gene expression analysis
Correlative StudyGenetic: microarray analysis
Correlative StudyGenetic: reverse transcriptase-polymerase chain reaction
Correlative StudyProcedure: adjuvant therapy
Metastatic growth controlProcedure: biopsy
Examination of tissue typeProcedure: conventional surgery
Tissue removalProcedure: neoadjuvant therapy
Tumor shrinkageProcedure: quality-of-life assessment
Correlative StudyRadiation: radiation therapy
Undergoing radiation therapy
- Determine the complete pathologic response (complete response [CR]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, and radiotherapy.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470184
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Nikhil Khushalani, MD||Roswell Park Cancer Institute|