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

Phase 2
18 Years
70 Years
Not Enrolling
Esophageal Cancer

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Trial Information

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.

Inclusion Criteria:

- Inpatients or outpatients, ≥ 18 years of age

- Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following
criteria (AJCC Staging System)

- cervical esophageal carcinoma, stage Ⅱ-Ⅲ

- upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal
carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused
and patient medically able to tolerate chemo-radiation.

- Evidence of unidimensional measurable disease as per Response Evaluation Criteria in
Solid Tumours (RECIST).

- ECOG Performance status of 0-1

- Effective contraception for both male and female patients if the risk of conception

- Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥
100,000 /mm^3, hemoglobin ≥ 9 g/dl

- Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine
clearance ≥ 60 ml/min

- Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN

- Tumor tissue available for KRAS biomarker test

- Signed written informed consent prior to study entry

Exclusion Criteria:

- Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery

- Concurrent chronic systemic immune therapy, targeted therapy not indicated in this
study protocol

- Multiple primary carcinomas of the esophagus

- Pregnancy (confirmed by serum or urine β-HCG) or lactation period;

- Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease

- Unable to comprehend the study requirements or who are not likely to comply with the
study parameters;

- Distant metastasis

- Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in
situ, or malignant disease, free for ≥ 5 years

- Known grade 3 or 4 allergic reaction to any of the study treatment

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Overall Response Rate (RR)

Outcome Description:

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.

Outcome Time Frame:

1 to 3 month after therapy

Safety Issue:


Principal Investigator

Jin Ming Yu, PH.D, M.D

Investigator Role:

Study Chair

Investigator Affiliation:

Shandong Cancer Hospital and Institute


China: Ethics Committee

Study ID:




Start Date:

January 2009

Completion Date:

July 2010

Related Keywords:

  • Esophageal Cancer
  • Therapeutic
  • Drug Therapy, combination
  • Radiotherapy
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms