NCT00470184

Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: 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

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	Oral
DRUG	oxaliplatin	IV
GENETIC	gene expression analysis	Correlative Study
GENETIC	microarray analysis	Correlative Study
GENETIC	reverse transcriptase-polymerase chain reaction	Correlative Study
PROCEDURE	adjuvant therapy	Metastatic growth control
PROCEDURE	biopsy	Examination of tissue type
PROCEDURE	conventional surgery	Tissue removal
PROCEDURE	neoadjuvant therapy	Tumor shrinkage
PROCEDURE	quality-of-life assessment	Correlative Study
RADIATION	radiation therapy	Undergoing radiation therapy

Timeline

• Start date: 2006-11-01
• Primary completion: 2012-10-01
• First posted: 2007-05-07
• Last updated: 2013-11-25
• Results posted: 2013-11-25

Locations

1 site across 1 country: United States