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| Name | Class |
|---|---|
| Unità Sperimentazioni cliniche | UNKNOWN |
| Istituto Nazionale Tumori di Napoli | UNKNOWN |
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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.
Study population: Locally advanced unresectable pancreatic cancer patients
Elegibility criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel and gemcitabine | Experimental | ARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle |
|
| Gemcitabine | Active Comparator | ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel and Gemcitabine | Drug | Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Rate | Assuming an expected progression rate in the control arm of 40% and an auspicated progression rate in the experimental arm of 20%,with one-tailed alpha=0.05, 80% power, 124 patients are required for the final analysis | progression rate is evaluated after 3 cycles of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Response | All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations | Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy |
| Esplore the effects of nab-paclitaxel in terms of toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Cascinu, PhD | GISCAD Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. Universitaria Ospedali Riuniti | Ancona | AN | 60100 | Italy | ||
| Istituto Tumori Giovanni Paolo II |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33812334 | Derived | Cascinu S, Berardi R, Bianco R, Bilancia D, Zaniboni A, Ferrari D, Mosconi S, Spallanzani A, Cavanna L, Leo S, Negri F, Beretta GD, Sobrero A, Banzi M, Morabito A, Bittoni A, Marciano R, Ferrara D, Noventa S, Piccirillo MC, Labianca R, Mosconi C, Casadei Gardini A, Gallo C, Perrone F. Nab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancreatic cancer - A GISCAD phase II randomized trial. Eur J Cancer. 2021 May;148:422-429. doi: 10.1016/j.ejca.2021.02.023. Epub 2021 Mar 31. |
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|
| Gemcitabine | Drug | gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle. |
|
|
Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade |
| every 3 cycles of chemotherapy |
| Progression Free Survival | Progression free survival time will be defined as the time from randomization until the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Patients who did not progress will be censored at the last date they were known to be alive. Patients who died of disease and for whom a date of progression is not available will be considered to have progressed on the day of their death | time from the start of the treatment until PD or death |
| Overall Survival | Overall survival time will be defined as the time from randomization to the date of death. If the subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow up). | the time from randomization to the date of death |
| Bari |
| BA |
| 70124 |
| Italy |
| A.O. Treviglio-Caravaggio, P.le Ospedale n1 | Treviglio | Bergamo | 24047 | Italy |
| A.O. Humanitas Gavazzeni | Bergamo | BG | 24125 | Italy |
| A.O. Ospedale G.Rummo | Benevento | BN | 82100 | Italy |
| ASDAA Bolzano | Bolzano | BZ | 39100 | Italy |
| Policlinico Universitario D.Casula | Monserrato | Cagliari | 09121 | Italy |
| Azienda Ospedaliera Sant'Anna | Como | CO | 22020 | Italy |
| A.O. Ospedale S.Martino | Genova | GE | 16132 | Italy |
| A.O. Polo Oncologico Vito Fazzi | Lecce | LE | 73100 | Italy |
| Azienda Ospedaliera San Gerardo di Monza, | Monza | MB | 20900 | Italy |
| Ospedale Civile | Legnano | MI | 20025 | Italy |
| Azienda Ospedaliera San Paolo | Milan | MI | 20142 | Italy |
| Policlinico | Modena | MO | 41142 | Italy |
| AUSL di Piacenza | Piacenza | PC | 29100 | Italy |
| ULSS15 di Camposampiero/Cittadella | Camposampiero | PD | 35012 | Italy |
| Ospedale Santa Croce | Fano | Pesaro | 61032 | Italy |
| Azienda Ospedaluiera Universitaria | Parma | PR | 43126 | Italy |
| A.O. S.Salvatore | Pesaro | PS | 61100 | Italy |
| IRCCS F.S. Maugeri | Pavia | PV | 27100 | Italy |
| Ospedale Civile | Vigevano | PV | 27029 | Italy |
| Azienda Ospedaliera Ospedale San Carlo | Potenza | PZ | 85100 | Italy |
| Ospedale Civile degli Infermi | Faenza | Ravenna | 48014 | Italy |
| Ospedale Umberto I | Lugo | Ravenna | 48022 | Italy |
| Azienda Ospedaliera | Ravenna | RA | 48121 | Italy |
| A.O. S.Maria Nuova - IRCCS | Reggio Emilia | RE | 42100 | Italy |
| Azienda Policlinico Umberto I | Roma | RM | 00161 | Italy |
| A.O. Cà Foncello | Treviso | TV | Italy |
| Ospedale di Circolo | Busto Arsizio | Varese | 21051 | Italy |
| AO Papa Giovanni XXIII | Bergamo | 24100 | Italy |
| Ospedale degli Infermi | Biella | 13900 | Italy |
| Casa di Cura di Poliambulanza, Via Bissolati 57 | Brescia | 25100 | Italy |
| A.O. Careggi-Università, Viale Pieraccini, 17 | Florence | 50139 | Italy |
| AOU Policlinico Universitario Federico II | Naples | 80131 | Italy |
| INT-IRCCS Fondazione G.Pascale | Naples | 80131 | Italy |
| Policlinico Universitario Campus Bio-Medico | Roma | 00128 | Italy |
| Policlinico Universitario A.Gemelli | Roma | 00168 | Italy |
| A.O. S.Giovanni Calabita Fatebenefratelli | Roma | 00186 | Italy |
| Ospedale di Sondrio | Sondrio | 23100 | 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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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