Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735345
Recruitment Status : Terminated (because of safety concerns the study was terminated prematurely)
First Posted : August 14, 2008
Last Update Posted : March 9, 2015
Merck Sharp & Dohme Corp.
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie

August 13, 2008
August 14, 2008
March 9, 2015
August 2008
December 2012   (Final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Duration of study ]
  • Percentage of complete remissions and resection rate [ Time Frame: Duration of study ]
Same as current
Complete list of historical versions of study NCT00735345 on Archive Site
  • Occurrence of toxicities [ Time Frame: Duration of study ]
  • Evaluation of Quality of Life [ Time Frame: Duration of study ]
Same as current
Not Provided
Not Provided
Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival.

This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable.

The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: 5-FU
    750 mg/m2/d C.I. i.v.d1-5, d29-33 and 300 mg/m2/d C.I. i.v. on the days of radiotherapy
  • Drug: Cisplatin
    15 mg/m2/d i.v. d1-5, d29-33
  • Drug: Taxotere
    75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78
    Other Name: Docetaxel
  • Biological: Cetuximab
    Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
    Other Name: Erbitux
  • Radiation: Radiation during chemoradio-immunotherapy
    39.6 Gy total dose
Experimental: Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
  • Drug: 5-FU
  • Drug: Cisplatin
  • Drug: Taxotere
  • Biological: Cetuximab
  • Radiation: Radiation during chemoradio-immunotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • histologically confirmed esophageal cancer (squamous cell carcinoma)
  • measurable, non-metastatic disease (uT1-4)
  • no previous cancer therapy (chemotherapy, radiotherapy or resection)
  • life expectancy > 3 months
  • age > 18 years
  • WHO Status ≤ 2
  • negative pregnancy test for women of child-bearing potential, and use of adequate contraception
  • hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
  • adequate renal function: serum creatinine ≤ 1,5 x ULN
  • adequate liver function: alkaline phosphatase < 2,5 x ULN, total bilirubin < 1,5 x ULN

Exclusion Criteria:

  • pregnant or nursing women
  • women of child-bearing potential without adequate contraception
  • concomitant anti-tumoral therapy except study mandated procedures
  • cervical esophageal cancer or diagnosis of metastases
  • participation in other clinical trials within the last 30 days
  • history of malignant disease within the last 5 years
  • peripheral neuropathy (NCI CTC ≥ grade 1)
  • concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
  • active infections
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT Nr. 2008-001016-21
Not Provided
Not Provided
Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
  • Merck Sharp & Dohme Corp.
  • Sanofi
Principal Investigator: Wolfgang Eisterer, Prof. Dr. Medizinische Universitaet Innsbruck
Arbeitsgemeinschaft medikamentoese Tumortherapie
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP