Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
GAP
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
1 other identifier
interventional
124
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Longer than P75 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedOctober 9, 2019
October 1, 2019
2.2 years
January 14, 2014
October 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Quality of Response
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
every 3 cycles of chemotherapy
Progression Free Survival
time from the start of the treatment until PD or death
Overall Survival
the time from randomization to the date of death
Study Arms (2)
nab-paclitaxel and gemcitabine
EXPERIMENTALARM 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 COMPARATORARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Interventions
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
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Previous chemotherapy or radiotherapy for pancreatic cancer
- Severe cardiovascular disease
- Thrombotic or embolic events
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- Known hypersensitivity to study drug
- Known drugs or alcohol abuse
- Pregnant or breastfeeding women
- Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
- Unable to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
A.O. Universitaria Ospedali Riuniti
Ancona, AN, 60100, Italy
Istituto Tumori Giovanni Paolo II
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
Napoli, 80131, Italy
INT-IRCCS Fondazione G.Pascale
Napoli, 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
Related Publications (1)
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.
PMID: 33812334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stefano Cascinu, PhD
GISCAD Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 23, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2016
Study Completion
January 14, 2019
Last Updated
October 9, 2019
Record last verified: 2019-10