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]

Table 2 Eligibility Criteria

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

ISSN: 1471-2407