A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)

Phase 2

Terminated

• Conditions: Pancreatic Cancer

• 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Kent Oncology Centre; 🇬🇧 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

The Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Christie Hospital NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Poole Hospital NHS Trust; 🇬🇧 Poole, United Kingdom

Clatterbridge Centre for Oncology NHS Foundation Trust; 🇬🇧 Wirral, United Kingdom