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)
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
UFT, Leucovorin
UFT/ Leucovorin + Cetuximab + Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- Kent Oncology Centre
- Royal Surrey County Hospital NHS Trust
- The Royal Marsden NHS Trust
- Aberdeen Royal Infirmary
- The Royal Bournemouth Hospital
- Christie Hospital NHS Foundation Trust
- Poole Hospital NHS Trust
- Clatterbridge Centre for Oncology NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
UFT/LV + RT
UFT/LV + RT + Cetuximab
Outcomes
Primary Outcome Measures
One year overall survival, measured from the date of registration.
Secondary Outcome Measures
Progression free survival
Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer
Objective response rate
Pattern of failure
Quality of life
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.
Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer.
Full Information
NCT ID
NCT01050426
First Posted
December 21, 2009
Last Updated
October 13, 2016
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Merck Serono International SA
1. Study Identification
Unique Protocol Identification Number
NCT01050426
Brief Title
A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
Acronym
PERU
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Data from other trials failed to demonstrate meaningful survival advantage
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Merck Serono International SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
UFT/LV + RT
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
UFT/LV + RT + Cetuximab
Intervention Type
Other
Intervention Name(s)
UFT, Leucovorin
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
UFT/ Leucovorin + Cetuximab + Radiotherapy
Intervention Description
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 Measure Information:
Title
One year overall survival, measured from the date of registration.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
three years
Title
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
Title
Objective response rate
Time Frame
three years
Title
Pattern of failure
Time Frame
up to 3 years
Title
Quality of life
Time Frame
up to 3 years
Title
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Time Frame
up to 3 years
Title
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.
Time Frame
up to 3 years
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Chau
Organizational Affiliation
The Royal Marsden NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kent Oncology Centre
City
Tunbridge Wells
State/Province
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Royal Surrey County Hospital NHS Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Poole Hospital NHS Trust
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
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