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2014-01
2016-03
2019-01-14
124
NCT02043730
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
INTERVENTIONAL
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
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: * 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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-01-14 | N/A | 2019-10-07 |
2014-01-21 | N/A | 2019-10-09 |
2014-01-23 | N/A | 2019-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: nab-paclitaxel and gemcitabine 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 | DRUG: Nab-paclitaxel and Gemcitabine
DRUG: Gemcitabine
|
| ACTIVE_COMPARATOR: Gemcitabine ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle. | DRUG: Nab-paclitaxel and Gemcitabine
DRUG: Gemcitabine
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
