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ISRCTN
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ISRCTN62866759
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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CapRI
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Serial number at source
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L-042/2003
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Study hypothesis
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The aim of this study is to evaluate the overall survival period attained by chemo-radiotherapy including interferon alpha-2b administration with adjuvant chemotherapy.
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Lay summary
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Ethics approval
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Ethics approval received from the ethics committee of the University of Heidelberg, Medical School (L-042/2003).
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Pancreatic cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/08/2004
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Anticipated end date
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31/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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110
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Interventions
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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.
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Primary outcome measure(s)
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Overall survival at two years postoperatively between two different methods of adjuvant treatment.
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Secondary outcome measure(s)
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1. Role and the mechanism of interferon alpha-2b in patient's chemoradiation regimen
2. Toxicity
3. Disease-free interval
4. Quality of life
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Sources of funding
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Manfred-Lautenschlager-Foundation, Gaiberg (Germany)
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Trial website
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Publications
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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
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Contact name
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Prof
Markus
Büchler
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 (0)6221 56 6201
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Fax
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+49 (0)6221 56 5450
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Email
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markus.buechler@med.uni-heidelberg.de
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Sponsor
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University of Heidelberg (Germany)
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Date applied
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23/11/2004
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Last edited
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18/08/2010
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Date ISRCTN assigned
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16/02/2005
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