Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT00735345
• Date of registration: 13/08/2008
• Prospective Registration: No
• Primary sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Public title: Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
• Scientific title: Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
• Date of first enrolment: August 2008
• Target sample size: 50
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00735345
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria

Contacts

• Name: Wolfgang Eisterer, Prof. Dr.
• Affiliation: Medizinische Universitaet Innsbruck

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Intervention(s)

Drug: Taxotere

Biological: Cetuximab

Radiation: Radiation during chemoradio-immunotherapy

Drug: 5-FU

Drug: Cisplatin

Primary Outcome(s)

Percentage of complete remissions and resection rate [Time Frame: Duration of study]

Response rate [Time Frame: Duration of study]

Secondary Outcome(s)

Occurrence of toxicities [Time Frame: Duration of study]

Evaluation of Quality of Life [Time Frame: Duration of study]

Secondary ID(s)

AGMT_ECa

EudraCT Nr. 2008-001016-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

Sanofi