NCT00815308

Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

An Open-labeled Study to Evaluate Efficacy of Combining Erbitux Plus Concurrent Chemo-radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Detailed description

Esophageal cancer is the sixth leading cause of cancer death worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor (TGF)-α. Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and radiation. For patients with locally advanced head and neck cancer, the combination of cetuximab and radiation has demonstrated both response and survival benefit. With all these, the investigators hypothesize that treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation may further improve clinical outcomes. This trial results will be important as it may support further studies for setting the new treatment standard for ESCC.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	cetuximab (Erbitux)	Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)
DRUG	Paclitaxel	Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)
DRUG	Cisplatin	Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)
RADIATION	Radiation	Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-12-30
• Last updated: 2011-02-08
• Results posted: 2011-02-03

Locations

1 site across 1 country: China