Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

Phase 2

Terminated

• Conditions: Esophageal Cancer
• Interventions: Drug: 5-FU; Drug: Cisplatin; Drug: Taxotere; Biological: Cetuximab; Radiation: Radiation during chemoradio-immunotherapy

• Registration Number: NCT00735345
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Taxotere	Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Treatment Arm	Cetuximab	Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Treatment Arm	Radiation during chemoradio-immunotherapy	Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Treatment Arm	Cisplatin	Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
Treatment Arm	5-FU	Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy

Primary Outcome Measures

Name	Time	Method
Response rate	Duration of study
Percentage of complete remissions and resection rate	Duration of study

Secondary Outcome Measures

Name	Time	Method
Occurrence of toxicities	Duration of study
Evaluation of Quality of Life	Duration of study

Trial Locations

Locations (7)

Universitätsklinik Innsbruck; 🇦🇹 Innsbruck, Austria

Universitätsklinikum Graz; 🇦🇹 Graz, Austria

A.ö. Landeskrankenhaus Leoben; 🇦🇹 Leoben, Austria

Klinikum Kreuzschwestern Wels GmbH; 🇦🇹 Wels, Austria

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Universitaetsklinik f. Innere Medizin III; 🇦🇹 Salzburg, Austria

Krankenhaus Barmherzige Brueder St. Veit a.d. Glan; 🇦🇹 St. Veit/ Glan, Austria