Plain English Summary
Background and study aims
Pancreatic cancer is cancer that starts in the pancreas (a gland that produces digestive juices and hormones). It can be treated with surgery to remove the cancer, followed by chemotherapy, where anti-cancer medicines are used to kill any cancerous cells left behind (adjuvant chemotherapy). This lowers the risk of the cancer coming back and prolongs patient survival, but its benefit is limited. Chemoradioimmunotherapy is a combination of chemotherapy, radiotherapy (which uses high energy rays to kill cancer cells) and immunotherapy (treatment that re-awakens the immune system so it can fight cancer). The aim of this study is to assess the effect of chemoradioimmunotherapy compared with adjuvant chemotherapy alone.
Who can participate?
Patients aged over 18 who have undergone surgery to completely remove pancreatic cancer within the last 12 weeks
What does the study involve?
Participants are randomly allocated to be treated with either chemoradioimmunotherapy (fluorouracil, cisplatin and interferon alfa-2b plus radiotherapy followed by two cycles of fluorouracil), or six cycles of adjuvant chemotherapy (fluorouracil). Patient survival is assessed two years later.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but there should be benefits to future patients with pancreatic cancer because the results of the study are likely to influence treatment. The main risk of the study will be side effects of the treatment. The participants will be closely monitored on a daily/weekly basis.
Where is the study run from?
The study has been set up by the University of Heidelberg in collaboration with various clinics in Germany and the Department of General and Oncological Surgery, Ospedale Mauriziano "Umberto I", Torino, Italy.
When is the study starting and how long is it expected to run for?
August 2004 to July 2006
Who is funding the study?
Manfred-Lautenschläger-Foundation (Germany)
Who is the main contact?
Prof. Dr med. M. W. Büchler
markus.buechler@med.uni-heidelberg.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Markus Büchler
ORCID ID
Contact details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6201
markus.buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
L-042/2003
Study information
Scientific 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
Acronym
CapRI
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.
Ethics approval
Ethics committee of the University of Heidelberg Medical School, ref: L-042/2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Pancreatic cancer
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Cisplatin, interferon alpha-2b, 5-fluorouracil (5-FU)
Primary outcome measures
Overall survival at two years postoperatively
Secondary outcome measures
1. Role and the mechanism of interferon alpha-2b in patient's chemoradiation regimen
2. Toxicity
3. Disease-free interval
4. Quality of life
Overall trial start date
01/08/2004
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant exclusion criteria
Does not comply with above inclusion criteria
Recruitment start date
01/08/2004
Recruitment end date
31/07/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Funders
Funder type
Research organisation
Funder name
Manfred-Lautenschlager-Foundation, Gaiberg (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
1. 2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15826316
2. 2006 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
Publication citations
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Protocol
Knaebel HP, Märten A, Schmidt J, Hoffmann K, Seiler C, Lindel K, Schmitz-Winnenthal H, Fritz S, Herrmann T, Goldschmidt H, Krempien R, Mansmann U, Debus J, Diehl V, Büchler MW, 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 -- CapRI: study protocol [ISRCTN62866759]., BMC Cancer, 2005, 5, 37, doi: 10.1186/1471-2407-5-37.
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Report on several cases
Hoffmann K, Marten A, Lindel K, Fritz S, Jager D, Buchler MW, Schmidt J, Major combined electrolyte deficiency during therapy with low-dose cisplatin, 5-fluorouracil and interferon alpha: report on several cases and review of the literature [ISRCTN62866759]., BMC Cancer, 2006, 6, 128, doi: 10.1186/1471-2407-6-128.
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Results
Schmidt J, Abel U, Debus J, Harig S, Hoffmann K, Herrmann T, Bartsch D, Klein J, Mansmann U, Jäger D, Capussotti L, Kunz R, Büchler MW, Open-label, multicenter, randomized phase III trial of adjuvant chemoradiation plus interferon Alfa-2b versus fluorouracil and folinic acid for patients with resected pancreatic adenocarcinoma., J. Clin. Oncol., 2012, 30, 33, 4077-4083, doi: 10.1200/JCO.2011.38.2960.