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]

After surgical intervention with curative intention in specialised
centres the five-year survival of patients with carcinoma of the
exocrine pancreas is only 15%. The ESPAC-1 trial showed an
increased five-year survival of 21% achieved with adjuvant
chemotherapy. Investigators from the Virginia Mason Clinic have
reported a 5-year survival rate of 55% in a phase II trial
evaluating adjuvant chemotherapy, immunotherapy and external-beam
radiation. Design: The CapRI study is an open, controlled,
prospective, randomised multi-centre phase III trial. Patients in
study arm A will be treated as outpatients with 5-Fluorouracil;
Cisplatin and 3 million units Interferon alpha-2b for 5 1/2 weeks
combined with external beam radiation. After chemo-radiation the
patients receive continuous 5-FU infusions for two more cycles.
Patients in study arm B will be treated as outpatients with
intravenous bolus injections of folinic acid, followed by
intravenous bolus injections of 5-FU given on 5 consecutive days
every 28 days for 6 cycles. A total of 110 patients with
specimen-proven R0 or R1 resected pancreatic adenocarcinoma will be
enrolled. An interim analysis for patient safety reasons will be
done one year after start of recruitment. Evaluation of the primary
endpoint will be performed two years after the last patients'
enrolment. Discussion: The aim of this study is to evaluate the
overall survival period attained by chemo-radiotherapy including
interferon alpha 2b administration with adjuvant chemotherapy. The
influence of interferon alpha on the effectiveness of the patients'
chemoradiation regimen, the toxicity, the disease-free interval and
the quality of life are analysed. Different factors are tested in
terms of their potential role as predictive markers.