Condition category
Cancer
Date applied
23/11/2004
Date assigned
16/02/2005
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Sponsor type

University/education

Website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

18/10/2016: Plain English summary added.