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

This study is currently recruiting participants.

Verified January 2010 by Royal Marsden NHS Foundation Trust

Sponsor:

Collaborator:

Merck Serono International SA

Information provided by:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01050426

First received: December 21, 2009

Last updated: January 14, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2009

Last Updated Date

January 14, 2010

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

One year overall survival, measured from the date of registration. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01050426 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: three years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Objective response rate [ Time Frame: three years ] [ Designated as safety issue: No ]
Pattern of failure [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

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)
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

Study Arm (s)

Active Comparator: Group 1
UFT/LV + RT

Intervention: Other: UFT, Leucovorin
Active Comparator: Group 2
UFT/LV + RT + Cetuximab

Intervention: Other: UFT/ Leucovorin + Cetuximab + Radiotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ian Chau		ian.chau@rmh.nhs.uk
Contact: Diana Tait		diana.tait@rmh.nhs.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01050426

Other Study ID Numbers ^ICMJE

3065

Has Data Monitoring Committee

Yes

Responsible Party

Ian Chau, Royal Marsden NHS Foundation Trust

Study Sponsor ^ICMJE

Royal Marsden NHS Foundation Trust

Collaborators ^ICMJE

Merck Serono International SA

Investigators ^ICMJE

Principal Investigator:

Ian Chau

The Royal Marsden NHS Trust

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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