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A phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinoma
ISRCTN ISRCTN62866759
DOI 10.1186/ISRCTN62866759
ClinicalTrials.gov identifier
EudraCT number
Public title A phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinoma
Scientific title
Acronym CapRI
Serial number at source L-042/2003
Study hypothesis The aim of this study is to evaluate the overall survival period attained by chemo-radiotherapy including interferon alpha-2b administration with adjuvant chemotherapy.
Lay summary Lay summary under review 2
Ethics approval Ethics approval received from the ethics committee of the University of Heidelberg, Medical School (L-042/2003).
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Pancreatic cancer
Participants - inclusion criteria 1. Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process (American Joint Committee on Cancer [AJCC] Stage I-III)
2. Protocol treatment must begin within 12 weeks of surgery
3. Men and women over eighteen years of age
Participants - exclusion criteria Does not comply with above inclusion criteria
Anticipated start date 01/08/2004
Anticipated end date 31/07/2006
Status of trial Completed
Patient information material
Target number of participants 110
Interventions Patients in study arm A will be treated with:
1. 200 mg/m^2/day 5-Fluorouracil (5-FU) by continuous intravenous (IV) infusion on days 1 - 38
2. 30 mg/m^2 Cisplatin IV over 60 minutes (with pre- and post-hydration) on days 1, 8, 15, 22, 29, 36 (6 doses)
3. 3 million units subcutaneous (SC) Interferon alpha-2b days 1 - 38 (17 total doses)

External beam radiation is to be given concurrently with chemotherapy with a total dose of 50.4 Gy in 28 fractions over 5.5 weeks (1.8 Gy/day).

In study arm A the patients receive post-chemoradiation 5-FU infusions of 200/mg/m^2/day by continuous intravenous infusion on days 64 - 101 and 120 - 161.

Patients in study arm B will be treated with 20 mg/m^2 intravenous bolus injection of Folinic acid, D-L form, followed by 425 mg/m^2/day intravenous bolus injection of 5-FU given on 5 consecutive days every 28 days for 6 cycles i.e. 24 weeks.
Primary outcome measure(s) Overall survival at two years postoperatively between two different methods of adjuvant treatment.
Secondary outcome measure(s) 1. Role and the mechanism of interferon alpha-2b in patient's chemoradiation regimen
2. Toxicity
3. Disease-free interval
4. Quality of life
Sources of funding Manfred-Lautenschlager-Foundation, Gaiberg (Germany)
Trial website
Publications 1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15826316
2. Report on several cases in http://www.ncbi.nlm.nih.gov/pubmed/16686958
3. 2010 Conference Proceedings:
CapRI: Final results of the open-label, multicenter, randomized phase III trial of adjuvant chemoradiation plus interferon-{alpha}2b (CRI) versus 5-FU alone for patients with resected pancreatic adenocarcinoma (PAC). Marten A, Schmidt J, Debus J, Harig S, Lindel K, Klein J, Bartsch DK, Capussotti L, Zülke C and Buchler M. Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 28, No 18_suppl (June 20 Supplement), 2010: LBA4012
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23008325
Contact name Prof  Markus  Büchler
  Address Im Neuenheimer Feld 110
  City/town Heidelberg
  Zip/Postcode 69120
  Country Germany
  Tel +49 (0)6221 56 6201
  Fax +49 (0)6221 56 5450
  Email markus.buechler@med.uni-heidelberg.de
Sponsor University of Heidelberg (Germany)
  Address Im Neuenheimer Feld 110
  City/town Heidelberg
  Zip/Postcode 69120
  Country Germany
Date applied 23/11/2004
Last edited 09/05/2013
Date ISRCTN assigned 16/02/2005
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