Clinical trial NCT00735345: Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Official title: Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Pre-operative
Chemo-immunotherapy
Radiochemo-immunotherapy
EGFR
Radiosensitivity
Resection
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Sanofi
First posted: 2008-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate
timeFrame: Duration of study
measure: Percentage of complete remissions and resection rate
timeFrame: Duration of study
Secondary outcomes:
measure: Occurrence of toxicities
timeFrame: Duration of study
measure: Evaluation of Quality of Life
timeFrame: Duration of study
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
city: Leoben
country: Austria
facility: A.ö. Landeskrankenhaus Leoben
city: Salzburg
country: Austria
facility: Universitaetsklinik f. Innere Medizin III
city: St. Veit/ Glan
country: Austria
facility: Krankenhaus Barmherzige Brueder St. Veit a.d. Glan
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
Study officials:
affiliation: Medizinische Universitaet Innsbruck
name: Wolfgang Eisterer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: