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
| ISRCTN | ISRCTN56652283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56652283 |
- Submission date
- 11/05/2005
- Registration date
- 13/06/2005
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Krempien
Scientific
Scientific
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Phone | +49 6221 568201 |
|---|---|
| robert_krempien@med.uni-heidelberg.de |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study acronym | PARC - Pancreatic Cancer Treatment with Radiotherapy and Cetuximab |
| Study objectives | Evaluation of EGFR targeting therapy with cetuximab in combination with radiotherapy and chemotherapy for locally advanced pancreatic cancer |
| Ethics approval(s) | No ethics information provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 66 |
| Key inclusion criteria | Patients with locally advanced primary inoperable pancreatic cancer |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
University Hospital
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Phone | +49 6221 568201 |
|---|---|
| robert_krempien@med.uni-heidelberg.de | |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
Industry
Merck KGaA, Darmstadt (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Study protocol | 11/10/2005 | Yes | No |
Editorial Notes
06/11/2019: Internal review.
