Spots Global Cancer Trial Database for Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
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Trial Identification
Brief Title: Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
Official Title: A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial
Study ID: NCT02043730
Conditions
Study Description
Brief Summary: Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management. Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.
Detailed Description: Study population: Locally advanced unresectable pancreatic cancer patients Elegibility criteria: * Written informed consent * Age \>18 \< 75 years * Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer * At least one lesion measurable with CT or MRI scan * Performance Status (ECOG) 0-1 at study entry * Life expectancy of at least 3 months * Adequate marrow, liver and renal function * Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O. Universitaria Ospedali Riuniti, Ancona, AN, Italy
Istituto Tumori Giovanni Paolo II, Bari, BA, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1, Treviglio, Bergamo, Italy
A.O. Humanitas Gavazzeni, Bergamo, BG, Italy
A.O. Ospedale G.Rummo, Benevento, BN, Italy
ASDAA Bolzano, Bolzano, BZ, Italy
Policlinico Universitario D.Casula, Monserrato, Cagliari, Italy
Azienda Ospedaliera Sant'Anna, Como, CO, Italy
A.O. Ospedale S.Martino, Genova, GE, Italy
A.O. Polo Oncologico Vito Fazzi, Lecce, LE, Italy
Azienda Ospedaliera San Gerardo di Monza,, Monza, MB, Italy
Ospedale Civile, Legnano, MI, Italy
Azienda Ospedaliera San Paolo, Milano, MI, Italy
Policlinico, Modena, MO, Italy
AUSL di Piacenza, Piacenza, PC, Italy
ULSS15 di Camposampiero/Cittadella, Camposampiero, PD, Italy
Ospedale Santa Croce, Fano, Pesaro, Italy
Azienda Ospedaluiera Universitaria, Parma, PR, Italy
A.O. S.Salvatore, Pesaro, PS, Italy
IRCCS F.S. Maugeri, Pavia, PV, Italy
Ospedale Civile, Vigevano, PV, Italy
Azienda Ospedaliera Ospedale San Carlo, Potenza, PZ, Italy
Ospedale Civile degli Infermi, Faenza, Ravenna, Italy
Ospedale Umberto I, Lugo, Ravenna, Italy
Azienda Ospedaliera, Ravenna, RA, Italy
A.O. S.Maria Nuova - IRCCS, Reggio Emilia, RE, Italy
Azienda Policlinico Umberto I, Roma, RM, Italy
A.O. Cà Foncello, Treviso, TV, Italy
Ospedale di Circolo, Busto Arsizio, Varese, Italy
AO Papa Giovanni XXIII, Bergamo, , Italy
Ospedale degli Infermi, Biella, , Italy
Casa di Cura di Poliambulanza, Via Bissolati 57, Brescia, , Italy
A.O. Careggi-Università, Viale Pieraccini, 17, Firenze, , Italy
AOU Policlinico Universitario Federico II, Napoli, , Italy
INT-IRCCS Fondazione G.Pascale, Napoli, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
Policlinico Universitario A.Gemelli, Roma, , Italy
A.O. S.Giovanni Calabita Fatebenefratelli, Roma, , Italy
Ospedale di Sondrio, Sondrio, , Italy
Contact Details
Name: Stefano Cascinu, PhD
Affiliation: GISCAD Foundation
Role: STUDY_CHAIR
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