Clinical trial NCT00470184
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2006-11-01; Completion date: 2012-10-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: 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
Interventions: intervention 1: capecitabine intervention 2: oxaliplatin intervention 3: gene expression analysis intervention 4: microarray analysis intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: adjuvant therapy intervention 7: biopsy intervention 8: conventional surgery intervention 9: neoadjuvant therapy intervention 10: quality-of-life assessment intervention 11: radiation therapy
Intervention descriptions: intervention 1: Oral intervention 2: IV intervention 3: Correlative Study intervention 4: Correlative Study intervention 5: Correlative Study intervention 6: Metastatic growth control intervention 7: Examination of tissue type intervention 8: Tissue removal intervention 9: Tumor shrinkage intervention 10: Correlative Study intervention 11: Undergoing radiation therapy

Protocol documents: