Status:
TERMINATED
Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Sanofi
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 p...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00735345
Start Date
August 1 2008
End Date
December 1 2012
Last Update
March 9 2015
Active Locations (7)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
2
Universitätsklinikum Graz
Graz, Austria, A-8036
3
Universitätsklinik Innsbruck
Innsbruck, Austria, A-6020
4
A.ö. Landeskrankenhaus Leoben
Leoben, Austria, A-8700