Pancreatic CancerPhase 2PERUNCT01050426
A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
A Phase 2 study testing UFT, Leucovorin and UFT/ Leucovorin + Cetuximab + Radiotherapy in people with Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- UFT, Leucovorin and UFT/ Leucovorin + Cetuximab + Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Mar 2009to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
The Royal Bournemouth Hospital
Bournemouth
Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
Poole Hospital NHS Trust
Poole, BH15 2JB
Kent Oncology Centre
Royal Tunbridge Wells, Maidstone, ME16 9QQ
The Royal Marsden NHS Trust
Sutton, Surrey, SM2 5PT
About this study
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)
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- UFT, Leucovorin, UFT/ Leucovorin + Cetuximab + Radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFT, LeucovorinOther
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)
UFT/ Leucovorin + Cetuximab + RadiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | UFT/LV + RT Receives: Other: UFT, Leucovorin |
| Group 2 | Active comparator | UFT/LV + RT + Cetuximab Receives: Other: UFT/ Leucovorin + Cetuximab + Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year overall survival, measured from the date of registration.
Measured: one year
Secondary outcomes (8)
Progression free survival
Measured: 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
Measured: three years
Objective response rate
Measured: three years
Pattern of failure
Measured: up to 3 years
Quality of life
Measured: up to 3 years
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Measured: up to 3 years
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.
Measured: 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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Data from other trials failed to demonstrate meaningful survival advantage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- Ian Chau, Principal investigator, The Royal Marsden NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050426
- Sponsor's protocol ID
- 3065
- Acronym
- PERU
- Status last verified
- Oct 2016
- First submitted
- 21 Dec 2009
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01050426
- Acronym / sponsor ID
- PERU / 3065
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data from other trials failed to demonstrate meaningful survival advantage
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: UFT, LeucovorinUFT/LV + RT |
| Group 2 | Active comparator | Other: UFT/ Leucovorin + Cetuximab + RadiotherapyUFT/LV + RT + Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UFT, LeucovorinUFT 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 | Group 1 |
| UFT/ Leucovorin + Cetuximab + RadiotherapyUFT 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 | Other | Group 2 |
Primary outcome
One year overall survival, measured from the date of registration.
Time frame: one year
8 secondary outcomes
Progression free survival
Time frame: 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
Objective response rate
Time frame: three years
Pattern of failure
Time frame: up to 3 years
Quality of life
Time frame: up to 3 years
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
Time frame: 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
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
Results and safety
The study was stopped early (reason given: Data from other trials failed to demonstrate meaningful survival advantage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Chau principal investigator
The Royal Marsden NHS Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UFT, Leucovorin and UFT/ Leucovorin + Cetuximab + Radiotherapy in people with Pancreatic Cancer, run by Royal Marsden NHS Foundation Trust at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data from other trials failed to demonstrate meaningful survival advantage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year overall survival, measured from the date of registration. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.