2009-03
2014-12
2014-12
17
NCT01050426
Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
INTERVENTIONAL
A 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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2009-12-21 | N/A | 2016-10-13 |
2010-01-14 | N/A | 2016-10-14 |
2010-01-15 | N/A | 2016-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1 UFT/LV + RT | OTHER: UFT, Leucovorin
|
ACTIVE_COMPARATOR: Group 2 UFT/LV + RT + Cetuximab | OTHER: UFT/ Leucovorin + Cetuximab + Radiotherapy
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
One year overall survival, measured from the date of registration. | one year |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Progression free survival | 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 | three years | |
Objective response rate | three years | |
Pattern of failure | up to 3 years | |
Quality of life | up to 3 years | |
Evaluation of molecular and genetic predictors of response to anti-EGFR treatment | up to 3 years | |
Evaluation of changes in diffusion weighted MRI parameters in pancreatic cancer patients before and after treatment. | 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. | up to 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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