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Table 2 Eligibility Criteria

From: Randomized phase II – study evaluating EGFR targeting therapy with Cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancer – PARC: study protocol [ISRCTN56652283]

Inclusion criteria Exclusion criteria
• Age equal or greater than 18 years
• Primary inoperable locally advanced pancreatic adenocarcinoma
• No evidence of metastatic disease.
• Hb >10.0 g/%, WBC >3,000 cells/mm3, platelets >100,000 cells/mm3.
• Performance status: Karnofsky ≥70.
• No acute infections at the time of therapy initiation.
• Patient must be able to give informed consent
• Patient has given informed consent
• Active infection
• Liver function impairment
• Pregnancy or breastfeeding.
• Metastatic disease
• Other severe systemic disease
• Second malignancy (except carcinoma in situ of the cervix uteri, basal cell carcinoma of the skin after adequate oncologic treatment)
• Any other experimental treatment 4 weeks before study inclusion
• Known positive HACA (human antichimeric antibody)
• Known allergy against extrinsical proteins
• Previous antibody therapy
• Allergy against iv contrast agent (for CT-scans)
• Previous chemo- and/or radiation treatment or EGFR-inhibitor therapy for pancreatic cancer
• Lack of compliance
• Inability to follow the instructions given by the investigator or the telephone interviewer (insufficient command of language, dementia, lack of time)
• Lack of informed consent