Randomized phase II Trial of combined chemoradiation with Epidermal Growth Factor Receptor (EGFR) antagonist Cetuximab versus combined chemoradiation with EGFR antagonist Cetuximab and sequential Cetuximab for patients with locally advanced pancreatic adenocarcinoma

Phase 2

Completed

• Conditions: Pancreatic adenocarcinoma; Cancer; Pancreatic

• Registration Number: ISRCTN56652283
• Lead Sponsor: niversity of Heidelberg (Germany)

Brief Summary

Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16219105

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-13
• Study Completion: 2007-12-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patients with locally advanced primary inoperable pancreatic cancer

Exclusion Criteria

1. Active infection
2. Liver function impairment
3. Pregnancy
4. Breast feeding
5. Metastatic disease
6. Elevated serum calcium level
7. Other severe systemic disease
8. Second malignancy (except carcinoma in situ of the cervix uteri, basal cell carcinoma of the skin after adequate oncologic treatment)
9. Any other experimental treatment four weeks before study inclusion
10. Known positive HACA (Human Anti-Chimeric Antibody)
11. Known allergy against extrinsical proteins
12. Previous antibody therapy
13. Allergy against intravenous (iv) contrast agent (for Computed Tomography [CT]-scans)
14. Previous chemo- and/or radiation treatment or EGFR-inhibitor therapy for pancreatic cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified