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Data from other trials failed to demonstrate meaningful survival advantage
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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | UFT/LV + RT |
|
| Group 2 | Active Comparator | UFT/LV + RT + Cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UFT, Leucovorin | Other | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| One year overall survival, measured from the date of registration. | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Chau | The Royal Marsden NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kent Oncology Centre | Royal Tunbridge Wells | Maidstone | ME16 9QQ | United Kingdom | ||
| Royal Surrey County Hospital NHS Trust |
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| UFT/ Leucovorin + Cetuximab + Radiotherapy | Other | 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 |
|
| 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 |
| Guildford |
| Surrey |
| GU2 7XX |
| United Kingdom |
| The Royal Marsden NHS Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| The Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Clatterbridge Centre for Oncology NHS Foundation Trust | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Poole Hospital NHS Trust | Poole | BH15 2JB | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005641 | Tegafur |
| D002955 | Leucovorin |
| D000068818 | Cetuximab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
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