A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
- Conditions
- Pancreatic Cancer
- Interventions
- Other: UFT/ Leucovorin + Cetuximab + RadiotherapyOther: UFT, Leucovorin
- Registration Number
- NCT01050426
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 UFT/ Leucovorin + Cetuximab + Radiotherapy UFT/LV + RT + Cetuximab Group 1 UFT, Leucovorin UFT/LV + RT
- Primary Outcome Measures
Name Time Method One year overall survival, measured from the date of registration. one year
- Secondary Outcome Measures
Name Time Method Objective response rate three years Quality of life 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 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 Pattern of failure up to 3 years Evaluation of molecular and genetic predictors of response to anti-EGFR treatment up to 3 years Progression free survival three years Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. up to 3 years
Trial Locations
- Locations (8)
Poole Hospital NHS Trust
🇬🇧Poole, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Kent Oncology Centre
🇬🇧Tunbridge Wells, Maidstone, United Kingdom
The Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
🇬🇧Wirral, United Kingdom
Royal Surrey County Hospital NHS Trust
🇬🇧Guildford, Surrey, United Kingdom
The Royal Marsden NHS Trust
🇬🇧Sutton, Surrey, United Kingdom