Esophageal Cancer
Conditions
Keywords
Esophageal cancer, Pre-operative, Chemo-immunotherapy, Radiochemo-immunotherapy, EGFR, Radiosensitivity, Resection
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.
Interventions
DRUG5-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
DRUGCisplatin
15 mg/m2/d i.v. d1-5, d29-33
DRUGTaxotere
75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78
BIOLOGICALCetuximab
Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
RADIATIONRadiation during chemoradio-immunotherapy
39.6 Gy total dose
Sponsors
Merck Sharp & Dohme LLC
Sanofi
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Duration of study |
| Percentage of complete remissions and resection rate | Duration of study |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of toxicities | Duration of study |
| Evaluation of Quality of Life | Duration of study |
Countries
Austria
Outcome results
None listed