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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021872-27 | EudraCT Number | ||
| GEMERLOXA | Other Identifier | ICO |
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Due to a low recruitment rate since start of recruitment period.
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Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop perioperative complications due to the complexity of surgery. In these patients there is also an increased risk of systemic relapse due to the advanced stage of the tumor as well as a higher possibility of having positive margins. Therefore, the treatment of these patients need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a very attractive therapeutic modality.
The neoadjuvant treatment offers the potential advantages of reducing the tumor stage, increasing resectability and decreasing postoperative complications.
The administration of chemotherapy and radiotherapy before surgery represent an strategy for early treatment of micrometastatic disease, present in most of these patients, and to identify patients with rapid progression of the disease.
For all the reasons above, the investigators consider it's of great interest to design new studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with neoadjuvant intention in patients with pancreas cancer locally advanced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QT + QRT | Experimental | Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day. Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1000mg/m2 / / 40mg/m2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. | Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival. | To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant). | Two years |
| Rate of resections with engative margins and complete pathological response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berta Laquente, MD | ICO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Català d'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| D000069347 | Erlotinib Hydrochloride |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Radiotherapy | Radiation | 50.4 Gy |
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| Tarceva | Drug | 100mg/day |
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| Oxaliplatin | Drug | 100mg/m2 (only in QT) |
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To determine the rate of negative margin resections and complete pathological response (cPR).
| Two years |
| Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9) | To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9). | Two years |
| Ratio of objective responses (RECIST). | To determine the ratio of objective responses according to RECIST criteria. | Two years |
| Prognosis accuracy of serum protein profiles | To determine the prognosis accuracy of serum protein profiles in these subjects. | Two years |
| Viability of the collection of pre-treatment tumor samples | To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment. | Two years |
| Adverse events | To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment. | Two years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |