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

October 13, 2016 updated by: Royal Marsden NHS Foundation Trust

A Multicentre Randomised Phase II 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Bournemouth, United Kingdom
        • The Royal Bournemouth Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Poole, United Kingdom, BH15 2JB
        • Poole Hospital NHS Trust
      • Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Foundation Trust
    • Maidstone
      • Tunbridge Wells, Maidstone, United Kingdom, ME16 9QQ
        • Kent Oncology Centre
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital NHS Trust
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Trust

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: three years
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
three years
Objective response rate
Time Frame: three years
three years
Pattern of failure
Time Frame: up to 3 years
up to 3 years
Quality of life
Time Frame: up to 3 years
up to 3 years
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Time Frame: up to 3 years
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
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
up to 3 years

Collaborators and Investigators

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

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Merck Serono International SA

Investigators

  • Principal Investigator: Ian Chau, The Royal Marsden NHS Trust

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 Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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