NCT02037048

FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma

A Phase II Trial of Modified FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Response Based Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Adenocarcinoma of the Esophagus, Gastro-esophageal Junction, and Gastric Cardia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil followed by surgery and response based concurrent chemotherapy and radiation therapy works in treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, paclitaxel, and carboplatin, 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 followed by surgery and response based chemotherapy and radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the ability of response adapted adjuvant chemoradiotherapy to improve the 1 year recurrence free survival (RFS) compared to historical data in patients with \> 50% remaining viable tumor after induction chemotherapy. SECONDARY OBJECTIVES: I. To determine the rates of symptomatic, endoscopic, and pathologic response to induction chemotherapy. II. To determine the rate of R0 resection after induction chemotherapy. III. To establish the toxicity profile of this tri-modality regimen. IV. To assess the recurrence free survival (RFS) and overall survival (OS) of this trimodality therapy regimen for the entire cohort and in patients who do and do not achieve a pathologic response. V. To assess patterns of failure and assess the rates of distant metastatic control (DMC) and locoregional control (LRC) of this tri-modality therapy regimen. EXPLORATORY OBJECTIVES: I. To evaluate the pattern of Ki-67 expression in patients with LRA esophageal cancer before and after induction chemotherapy. II. To explore the relationship of Ki-67 expression to clinical and pathologic response parameters as well as survival outcomes. III. To evaluate the relationship between human epidermal growth factor receptor 2 (HER2) overexpression (based on immunohistochemistry) and gene amplification (based on fluorescence in situ hybridization) with clinical and pathologic response parameters and survival outcomes. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive oxaliplatin intravenously (IV) over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 44 hours on days 1-3. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-5 weeks after completion of induction chemotherapy, patients undergo a surgical procedure. The choice of surgical procedure is at the discretion of the operating physician. ADJUVANT THERAPY: Within 6-12 weeks after surgery, patients undergo radiation therapy for 28 days. Patients with a positive pathological response also receive oxaliplatin, leucovorin calcium, and fluorouracil as in the induction chemotherapy, beginning days 1, 15, and 29 concurrent with radiation therapy. Patients with a negative pathological response receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients with locoregional disease only after induction therapy but do not undergo surgery may receive chemoradiotherapy with carboplatin and paclitaxel as determined by the primary oncologist. After completion of study treatment, patients are followed up every 3 months for 2 years, every 4-5 months for 3 years, and then annually thereafter.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Adenocarcinoma of the Gastric Cardia
• Stage IIIA Esophageal Cancer
• Stage IIIB Esophageal Cancer
• Stage IIIC Esophageal Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	Given IV
DRUG	leucovorin calcium	Given IV
DRUG	fluorouracil	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo therapeutic conventional surgery
RADIATION	radiation therapy	Undergo radiation therapy
DRUG	carboplatin	Given IV
DRUG	paclitaxel	Given IV

Timeline

• Start date: 2014-02-10
• Primary completion: 2022-03-18
• Completion: 2025-10-01
• First posted: 2014-01-15
• Last updated: 2024-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study