Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

NCT ID: NCT00735345

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-12-31

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 patients with non-metastatic esophageal cancer.

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy

Group Type: EXPERIMENTAL

5-FU

Intervention Type: DRUG

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

Intervention Type: DRUG

15 mg/m2/d i.v. d1-5, d29-33

Taxotere

Intervention Type: DRUG

75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78

Cetuximab

Intervention Type: BIOLOGICAL

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

Radiation during chemoradio-immunotherapy

Intervention Type: RADIATION

39.6 Gy total dose

Interventions

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

Intervention Type: DRUG

Cisplatin

15 mg/m2/d i.v. d1-5, d29-33

Intervention Type: DRUG

Taxotere

75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78

Intervention Type: DRUG

Cetuximab

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

Intervention Type: BIOLOGICAL

Radiation during chemoradio-immunotherapy

39.6 Gy total dose

Intervention Type: RADIATION

Other Intervention Names

Docetaxel; Erbitux

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Arbeitsgemeinschaft medikamentoese Tumortherapie

Principal Investigators

Wolfgang Eisterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universitaet Innsbruck

Locations

Landeskrankenhaus Feldkirch

Feldkirch, , Austria

Universitätsklinikum Graz

Graz, , Austria

Universitätsklinik Innsbruck

Innsbruck, , Austria

A.ö. Landeskrankenhaus Leoben

Leoben, , Austria

Krankenhaus Barmherzige Brueder St. Veit a.d. Glan

Saint Veit/ Glan, , Austria

Universitaetsklinik f. Innere Medizin III

Salzburg, , Austria

Klinikum Kreuzschwestern Wels GmbH

Wels, , Austria

Countries

Austria

Other Identifiers

EudraCT Nr. 2008-001016-21

Identifier Type: -

Identifier Source: secondary_id

AGMT_ECa

Identifier Type: -

Identifier Source: org_study_id