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
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: 5-FU
Drug: Cisplatin
Drug: Taxotere
Biological: Cetuximab
Radiation: Radiation during chemoradio-immunotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735345

Locations
Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
Universitätsklinikum Graz
Graz, Austria, A-8036
Universitätsklinik Innsbruck
Innsbruck, Austria, A-6020
A.ö. Landeskrankenhaus Leoben
Leoben, Austria, A-8700
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020
Krankenhaus Barmherzige Brueder St. Veit a.d. Glan
St. Veit/ Glan, Austria, A-9300
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, A-4600
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme Corp.
Sanofi
Investigators
Principal Investigator: Wolfgang Eisterer, Prof. Dr. Medizinische Universitaet Innsbruck
  More Information

No publications provided

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00735345     History of Changes
Other Study ID Numbers: AGMT_ECa, EudraCT Nr. 2008-001016-21
Study First Received: August 13, 2008
Last Updated: October 6, 2010
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Esophageal cancer
Pre-operative
Chemo-immunotherapy
Radiochemo-immunotherapy
EGFR
Radiosensitivity
Resection

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014