Clinical trialPhase 2Completed
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
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
- Outcome
- Finished, no results posted
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- January 2014
- Expected end
- 14 January 2019
- Enrollment
- 124 participants
- Sites
- 39
- Primary outcomes
- Progression Rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 9 October 2019
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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
Papers 1
- Registry-listed results paperNab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancr… DOI 10.1016/j.ejca.2021.02.023↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.