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 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Markus Büchler
Scientific

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone +49 (0)6221 56 6201
Email markus.buechler@med.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA 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 acronymCapRI
Study objectivesThe 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) studiedPancreatic cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Cisplatin, interferon alpha-2b, 5-fluorouracil (5-FU)
Primary outcome measureOverall survival at two years postoperatively
Secondary outcome measures1. 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 date01/08/2004
Completion date31/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants110
Key inclusion criteria1. 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 criteriaDoes not comply with above inclusion criteria
Date of first enrolment01/08/2004
Date of final enrolment31/07/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Sponsor information

University of Heidelberg (Germany)
University/education

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

ROR logo "ROR" https://ror.org/038t36y30

Funders

Funder type

Research organisation

Manfred-Lautenschlager-Foundation, Gaiberg (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.