Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
18 Years
N/A
Both
Esophageal Cancer
Trial Information
Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
Duration of study
Safety Issue:
No
Principal Investigator
Wolfgang Eisterer, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medizinische Universitaet Innsbruck
Authority:
Austria: Ethikkommission
Study ID:
AGMT_ECa
NCT ID:
NCT00735345
Start Date:
August 2008
Completion Date:
December 2012
Related Keywords:
- Esophageal Cancer
- Esophageal cancer
- Pre-operative
- Chemo-immunotherapy
- Radiochemo-immunotherapy
- EGFR
- Radiosensitivity
- Resection
- Carcinoma
- Esophageal Diseases
- Esophageal Neoplasms
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