Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

This study has been terminated.
(because of safety concerns the study was terminated prematurely)
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00735345
First received: August 13, 2008
Last updated: October 6, 2010
Last verified: October 2010

August 13, 2008
October 6, 2010
August 2008
December 2012   (final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Percentage of complete remissions and resection rate [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00735345 on ClinicalTrials.gov Archive Site
  • Occurrence of toxicities [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Evaluation of Quality of Life [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
    Other Name: Cisplatin
  • 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
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00735345
AGMT_ECa, EudraCT Nr. 2008-001016-21
No
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
October 2010

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