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The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy | Experimental | After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11). |
|
| surgery | Active Comparator | surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration). | from date of randomization until date of progression, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| histology | histological response, | at 6 months |
| overall survival | time from date of inclusion to date of death | From date of randomization until date of death, assessed up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc RAOUL, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | 13009 | France |
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| Label | URL |
|---|---|
| official web site of the sponsor | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| surgery and Adjuvant chemotherapy | Procedure | surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks. |
|
| complication | complication rates after surgery, | until 6 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |