A phase II study with oxaliplatin, 5FU, Cetuximab and radiotherapy for treatment of non-resectable, locally advanced tu not metastatic cancer of oersophagus or the cardia regio
- Conditions
- Patients with histologically verified inoperable, locally advanced but non metastastic oesophageal ca or the ca of cardia region
- Registration Number
- EUCTR2008-006802-40-NO
- Lead Sponsor
- Akademiska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
•Histologically verified squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia (Siewert I-II)
•Performance status (WHO) 0-2, age 18-80 y
•Locally advanced disease non-resectable (T4 N0-N3, M0) or disease which is not operable for any other reason (T2/T3 N0-N3, M0)
•Adequate hematological, liver and renal function
•Written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Distant metastases
•Prior chemotherapy or radiotherapy for oesophageal ca or ca of the cardia region
•Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
•Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed concent
•Myocardial infarction within 6 months prior to study entry
•Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years
•Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method