An Open-labeled Study to Evaluate Efficacy of Combining Erbitux Plus Concurrent Chemo-radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response Rate (RR)
The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
1 to 3 month after therapy
Jin Ming Yu, PH.D, M.D
Shandong Cancer Hospital and Institute
China: Ethics Committee