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

Study Overview

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

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.

Pancreatic Cancer

OTHER: UFT, Leucovorin
OTHER: UFT/ Leucovorin + Cetuximab + Radiotherapy

3065

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-13
First Submitted that Met QC Criteria 2010-01-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-14
First Posted (ESTIMATED) 2010-01-15	Results First Posted N/A	Last Verified 2016-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Group 1 UFT/LV + RT	OTHER: UFT, 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)
ACTIVE_COMPARATOR: Group 2 UFT/LV + RT + Cetuximab	OTHER: UFT/ 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

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Group 1

UFT/LV + RT

OTHER: UFT, 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)

ACTIVE_COMPARATOR: Group 2

UFT/LV + RT + Cetuximab

OTHER: UFT/ 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

Primary Outcome Measures	Measure Description	Time Frame
One year overall survival, measured from the date of registration.		one year

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival		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		three years
Objective response rate		three years
Pattern of failure		up to 3 years
Quality of life		up to 3 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Serono International SA

Investigators

PRINCIPAL_INVESTIGATOR: Ian Chau, The Royal Marsden NHS Trust

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record