Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Terminated; Phase 2

Conditions: Esophageal Cancer

Treatments: Biological: Cetuximab; Drug: 5-FU; Radiation: Radiation during chemoradio-immunotherapy; Drug: Taxotere; Drug: Cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00735345

EudraCT Nr. 2008-001016-21

AGMT_ECa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment Arm

Experimental group

Description:

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

Treatment:

Drug: 5-FU

Drug: Taxotere

Radiation: Radiation during chemoradio-immunotherapy

Drug: Cisplatin

Biological: Cetuximab