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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.

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. - OE-7

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001097-24-DE
Enrollment
Unknown
Registered
2006-05-22
Start date
2007-07-19
Completion date
Unknown
Last updated
2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced oesophageal squamous cell carcinoma

Interventions

Trade Name: Erbitux 5 mg/ml Product Name: Erbitux 5mg/ml Pharmaceutical Form: Solution for infusion Trade Name: Oxaliplatin Product Name: Oxaliplatin Pharmaceutical Form: Solution for infusion INN o

Sponsors

Technische Universitaet Muenchen, Medizinische Fakultaet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 - Assessment of adverse effects - Assessment of overall survival - Assessment of R0 resection rate ;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. Phase 2: Response Rate;Timepoint(s) of evaluation of this end point: Phase 1: After inclusion of first 12 subjects, evaluation of dose Phase 2: After surgery of the patient—

Secondary

MeasureTime frame
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; last endpoint will be assessed after 5 years of follow-up (post-operatively)—

Countries

Germany

Contacts

Public ContactDr. Christiane Blankenstein

Technische Universitaet Muenchen, Klinikum rechts der Isar, Muenchner Studienzentrum

christiane.blankenstein@mri.tum.de498941406320

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026