Phase I/II study of continous infusion with 5-FU and weekly Oxaliplatin / Cetuximab combined with concurrent radiation as neoadjuvant treatment in locally advanced oesophageal squamous cell carcinoma.

Active, not recruiting

• Conditions: ocally advanced oesophageal squamous cell carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001097-24-DE
• Lead Sponsor: Technische Universitaet Muenchen, Medizinische Fakultaet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-22
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Histologically confirmed oesophageal squamos cell carcinoma
- Potentially resectable locally advanced oesophageal carcinoma
- Locally advanced stage (>uT3 category / >uT2 in cervical cancer) according to endoscopic ultrasound and computed tomography
- Medically operable patient: risk-score <22 (Bartels)
- Age 18 to 70 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Distant metastases
- Tumour infiltration into the tracheo-bronchial system
- Previous chemotherapy or radiation in the area ot the chest
- Uncontrolled infectious disease
- Manifest cardiac insufficiency
- Histologically assured cirrhosis of the liver

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Definition of the maximal tolerated dose for the combination of Cetuximab plus Oxaliplatin combined with concurrent radiation as neoadjuvant treatment;Secondary Objective: - Assessment of response<br>- Assessment of adverse effects<br>- Assessment of overall survival<br>- Assessment of R0 resection rate<br>;Primary end point(s): Phase 1: Definition of the maximal tolerated dose for the combination of Cetuximab plus Oxaliplatin combined with concurrent radiation as neoadjuvant treatment. <br>Phase 2: Response Rate;Timepoint(s) of evaluation of this end point: Phase 1: After inclusion of first 12 subjects, evaluation of dose<br>Phase 2: After surgery of the patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of toxicity, rate of post-surgery complications, RO-resection rate, overall survival, disease free survival, metabolic response rate;Timepoint(s) of evaluation of this end point: post surgery; <br>last endpoint will be assessed after 5 years of follow-up (post-operatively)