The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.
Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer. Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
UFT 300mg/m2/day in 3 equal doses and Leucovorin 90mg/day in 3 divided doses per day given daily on the days of radiotherapy only (30 days in total)
UFT 300mg/m2 + LV 90mg/day on days of RT only (30 days in total), Cetuximab 400mg/m2 week 1, thereafter 250mg/m2 weeks 2-6
Kent Oncology Centre
Royal Tunbridge Wells, Maidstone, United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford, Surrey, United Kingdom
The Royal Marsden NHS Trust
Sutton, Surrey, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
One year overall survival, measured from the date of registration.
Time frame: one year
Progression free survival
Time frame: three years
Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer
Time frame: three years
Objective response rate
Time frame: three years
Pattern of failure
Time frame: up to 3 years
Quality of life
Time frame: up to 3 years
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Time frame: up to 3 years
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.
Time frame: up to 3 years
Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer.
Time frame: up to 3 years
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The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Poole Hospital NHS Trust
Poole, United Kingdom