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| Name | Class |
|---|---|
| Gruppo Oncologico Italia Meridionale | OTHER |
| Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente | OTHER |
| Gruppo Oncologico Italiano di Ricerca Clinica | OTHER |
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The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | cisplatin + gemcitabine |
|
| B | Active Comparator | gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical benefit response | baseline and at end of every cycle of therapy | |
| quality of life | baseline and at end of every cycle of therapy | |
| objective response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Colucci, M.D. | Istituto Tumori Giovanni Paolo II | Principal Investigator |
| Roberto Labianca, M.D. | Ospedale Riuniti Bergamo | Principal Investigator |
| Francesco Di Costanzo, M.D. | Azienda Ospedaliera Careggi | Principal Investigator |
| Stefano Cascinu, M.D. | Ospedale Riuniti Umberto I-Lancise-Salese | Principal Investigator |
| Paolo Pederzoli, M.D. | Policlinico G.B. Rossi, Verona | Principal Investigator |
| Ciro Gallo, M.D., Ph.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Francesco Perrone, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedal Miulli | Acquaviva delle Fonti | Italy | ||||
| Ospedale Regionale Torrette |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20194854 | Derived | Colucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51. doi: 10.1200/JCO.2009.25.4433. Epub 2010 Mar 1. |
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| Cattedra di Endocrinochirurgia, Università di Verona |
| UNKNOWN |
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| cisplatin | Drug | 25 mg/m2 IV on days 1, 8, and 15 every 4 weeks |
|
| after 7 weeks of therapy |
| time to progression | 6 months |
| Ancona |
| Italy |
| Presidio Osp. Alto Garda e Ledro | Arco | Italy |
| Centro Riferimento Oncologico | Aviano | Italy |
| Istituto Oncologico Giovanni Paolo II | Bari | Italy |
| Azienda Ospedaliera G. Rummo | Benevento | Italy |
| Ospedale Fatebenefratelli | Benevento | Italy |
| Ospedale Riuniti | Bergamo | Italy |
| Ospedale degli Infermi | Biella | Italy |
| Ospedale Regionale | Bolzano | Italy |
| Policlinico Universitario | Cagliari | Italy |
| Ospedale A. Cardarelli | Campobasso | Italy |
| Ospedale Ramazzini | Carpi | Italy |
| Centro Catanese di Oncologia | Catania | Italy |
| Università di Chieti "D'Annunzio" | Chieti | Italy |
| Ospedale Valduce | Como | Italy |
| Ospedale Santa Croce | Fano | Italy |
| Azienda Ospedaliera Universitaria | Ferrara | Italy |
| Azienda Ospedale Careggi | Florence | Italy |
| Azienda Ospedaliera Vito Fazzi | Lecce | Italy |
| Ospedale Umberto I | Lugo | Italy |
| Pres. Osp. di Manerbio | Manerbio | Italy |
| Ospedale L. Sacco | Milan | Italy |
| Ospedale San Paolo | Milan | Italy |
| Ospedale G. Moscati | Monteforte Irpino | Italy |
| Ospedale San Gerardo | Monza | Italy |
| Istituto Nazionale Tumori | Naples | Italy |
| Ospedale Cardarelli | Naples | Italy |
| Ospedale Civile | Olbia | Italy |
| Casa di Cura La Maddalena | Palermo | Italy |
| Policlinico Giaccone | Palermo | Italy |
| Ospedale San Salvatore-Muraglia | Pesaro | Italy |
| Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| Ospedale San Carlo | Potenza | Italy |
| Azienda Policlinico S. Andrea | Roma | Italy |
| Ospedale Fatebenefratelli | Roma | Italy |
| Ospedale San Raffaele | Roma | Italy |
| Policlinico Militare Celio | Roma | Italy |
| Polo Oncologico Istituto Regina Elena | Roma | Italy |
| Ospedale Civile | Rovereto | Italy |
| Ospedale Civile | Rovigo | Italy |
| Centro Oncologico | S. Vito Al Tagliamento | Italy |
| Ospedale Santa Chiara | Trento | Italy |
| Azienda Ospedaliera Treviglio-Caravaggio | Treviglio | Italy |
| Ospedale San Bortolo | Vicenza | Italy |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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