Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021738-72 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Erlotinib and radiotherapy | Experimental | Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine and Erlotinib | Drug | Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the safety of the treatment | Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events. Safety population will include all subjects that have taken at least one study medication dose. | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan Maurel, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain | ||
| Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30225601 | Derived | Maurel J, Sanchez-Cabus S, Laquente B, Gaba L, Visa L, Fabregat J, Poves I, Rosello S, Diaz-Beveridge R, Martin-Richard M, Rodriguez J, Sabater L, Conill C, Cambray M, Reig A, Ayuso JR, Valls C, Ferrandez A, Bombi JA, Gines A, Garcia-Albeniz X, Fernandez-Cruz L. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine-erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial). Cancer Chemother Pharmacol. 2018 Dec;82(6):935-943. doi: 10.1007/s00280-018-3682-9. Epub 2018 Sep 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Evaluate the response rate using RECIST criteria | 3 years |
| Evaluate the percentage of resectability | 3 years |
| Evaluate the percentage of lymphatic nodes removed | 3 years |
| Evaluate the percentage of lymphatic nodes involved | 3 years |
| Evaluate the pathological regression stage (primary tumor and lymphatic nodes) | 3 years |
| Relate RECIST criteria with the pathological regress stage | 3 years |
| Measure the progression free survival (time from the inclusion date to the progression of the disease or death) | 3 years |
| Evaluate the overall survival time | 3 years |
| Barcelona |
| 08003 |
| Spain |
| Institut Català d'Oncologia (ICO) de L'Hospitalet | Barcelona | 08007 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Santa Creu y Sant Pau, Hospital Sant Pau | Barcelona | 08041 | Spain |
| Instituto Catalán de Oncología | Girona | 17007 | Spain |
| Hospital Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital la Fe de Valencia | Valencia | 46009 | Spain |
| Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |