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 |
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DOI | https://doi.org/10.1186/ISRCTN62866759 |
Secondary identifying numbers | L-042/2003 |
- Submission date
- 23/11/2004
- Registration date
- 16/02/2005
- Last edited
- 18/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Phone | +49 (0)6221 56 6201 |
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markus.buechler@med.uni-heidelberg.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
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 |
Study acronym | CapRI |
Study objectives | 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(s) | Ethics committee of the University of Heidelberg Medical School, ref: L-042/2003 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Cisplatin, interferon alpha-2b, 5-fluorouracil (5-FU) |
Primary outcome measure | 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 study start date | 01/08/2004 |
Completion date | 31/07/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 110 |
Key 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 |
Key exclusion criteria | Does not comply with above inclusion criteria |
Date of first enrolment | 01/08/2004 |
Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
69120
Germany
Sponsor information
University/education
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
https://ror.org/038t36y30 |
Funders
Funder type
Research organisation
No information available
Results and Publications
Intention to publish date | |
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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 | protocol | 12/04/2005 | Yes | No | |
Other publications | report on several cases | 10/05/2006 | Yes | No | |
Abstract results | abstract LBA4012 | 20/06/2010 | No | No | |
Results article | results | 20/11/2012 | Yes | No |
Editorial Notes
18/10/2016: Plain English summary added.