Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERUFT, Leucovorin
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)
OTHERUFT/ Leucovorin + Cetuximab + Radiotherapy
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
Sponsors
Merck Serono International SA
Royal Marsden NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas. * Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta. * Performance status 0-2 * No evidence of metastatic disease as determined by CT scan/ other investigations * Adequate bone marrow function with platelets\>100\^9/l; WBC\>3x10\^9/l;neutrophils\> 1.5x10\^9/l * Serum bilirubin ,1.5 x ULN and transaminases \< 2.5 x ULN * Calculated/measured GFR \>50ml/min * No concurrent uncontrolled medical condition * No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years * Life expectancy \> 3months * Adequate contraceptive precautions * Informed written consent
Exclusion criteria
* medical or psychiatric conditions that compromise the patient's ability to give informed consent * Presence of met. disease * Concurrent uncontrolled medical conditions * Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer. * Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry * Adjuvant RT with/without chemo for pancreatic cancer. * Pregnancy/breast feeding * Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract. * Patients with a known hypersensitivity to 5-FU or with a DPD deficiency. * Clinically significant CVD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One year overall survival, measured from the date of registration. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer | three years |
| Objective response rate | three years |
| Pattern of failure | up to 3 years |
| Progression free survival | three years |
| Evaluation of molecular and genetic predictors of response to anti-EGFR treatment | up to 3 years |
| Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. | 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. | up to 3 years |
| Quality of life | up to 3 years |
Countries
United Kingdom
Outcome results
None listed