Clinical trial NCT01050426: 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: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2010-01-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: One year overall survival, measured from the date of registration.
timeFrame: one year
Secondary outcomes:
measure: Progression free survival
timeFrame: three years
measure: Characterise safety profile of UFT/leucovorin, radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer
timeFrame: three years
measure: Objective response rate
timeFrame: three years
measure: Pattern of failure
timeFrame: up to 3 years
measure: Quality of life
timeFrame: up to 3 years
measure: Evaluation of molecular and genetic predictors of response to anti-EGFR treatment
timeFrame: up to 3 years
measure: Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment.
timeFrame: up to 3 years
measure: Evaluation of the role of FDG-PET in predicting overall survival, progression free survival and objective response rate in locally advanced pancreatic cancer.
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Kent Oncology Centre
state: Maidstone
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Trust
state: Surrey
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Trust
state: Surrey
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Trust
city: Wirral
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Foundation Trust
Study officials:
affiliation: The Royal Marsden NHS Trust
name: Ian Chau
role: PRINCIPAL_INVESTIGATOR
References: