Condition category
Cancer
Date applied
11/05/2005
Date assigned
13/06/2005
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

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

Randomised 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 measures

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

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

Additional files

Editorial Notes