Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

Esophageal Cancer Clinical Trial

Official title:

Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735345
• Other study ID #: AGMT_ECa
• Secondary ID: EudraCT Nr. 2008
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2008
• Last updated: March 6, 2015
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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 patients with non-metastatic esophageal cancer.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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
• Cisplatin
15 mg/m2/d i.v. d1-5, d29-33
• Taxotere
75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78

Biological:
• Cetuximab
Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85

Radiation:
• Radiation during chemoradio-immunotherapy
39.6 Gy total dose

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Universitätsklinikum Graz	Graz
Austria	Universitätsklinik Innsbruck	Innsbruck
Austria	A.ö. Landeskrankenhaus Leoben	Leoben
Austria	Universitaetsklinik f. Innere Medizin III	Salzburg
Austria	Krankenhaus Barmherzige Brueder St. Veit a.d. Glan	St. Veit/ Glan
Austria	Klinikum Kreuzschwestern Wels GmbH	Wels

Sponsors (3)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Merck Sharp & Dohme Corp., Sanofi

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Duration of study	No
Primary	Percentage of complete remissions and resection rate		Duration of study	No
Secondary	Occurrence of toxicities		Duration of study	Yes
Secondary	Evaluation of Quality of Life		Duration of study	No