Contact information
Type
Scientific
Primary contact
Dr Robert Krempien
ORCID ID
Contact details
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 6221 568201
robert_krempien@med.uni-heidelberg.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
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
Acronym
PARC - Pancreatic Cancer Treatment with Radiotherapy and Cetuximab
Study hypothesis
Evaluation of EGFR targeting therapy with cetuximab in combination with radiotherapy and chemotherapy for locally advanced pancreatic cancer
Ethics approval
No ethics information provided at time of registration.
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Pancreatic adenocarcinoma
Intervention
Two arm phase I/II study:
Arm A: radiotherapy and concurrent gemcitabine and EGFR antagonist cetuximab with sequential gemcitabine
Arm B: radiotherapy and concurrent gemcitabine and EGFR antagonist cetuximab with sequential gemcitabine and EGFR antagonist cetuximab
Intervention type
Drug
Phase
Phase II
Drug names
Cetuximab
Primary outcome measure
Safety, feasibility and side effects of the combination therapy of chemoradiation and cetuximab
Secondary outcome measures
1. Response
2. Time to progress
3. Operability after treatment
4. Time to treatment failure
Overall trial start date
01/01/2005
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with locally advanced primary inoperable pancreatic cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg (Germany)
Sponsor details
University Hospital
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 6221 568201
robert_krempien@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Merck KGaA, Darmstadt (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16219105
Publication citations
-
Study protocol
Krempien R, Muenter MW, Huber PE, Nill S, Friess H, Timke C, Didinger B, Buechler P, Heeger S, Herfarth KK, Abdollahi A, Buchler MW, Debus J, 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]., BMC Cancer, 2005, 5, 131, doi: 10.1186/1471-2407-5-131.