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 design	Randomised controlled trial
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
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

Im Neuenheimer Feld 110

Heidelberg
69120
Germany

Sponsor information

University of Heidelberg (Germany)
University/education

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

"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 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	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.