Clinical trialPhase 2Completed
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- November 2015
- Expected end
- March 2021
- Enrollment
- 127 participants
- Sites
- 37
- Primary outcomes
- Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization
- Sponsor
- Other
- Results posted
- 2024-07-09
- Last update
- 9 July 2024
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Brief summary public domain (ClinicalTrials.gov)
The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization [6 months after randomization]. Count Of Participants, Participants. Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 28; Nab-paclitaxel + Gemcitabine (n=60): 14.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS): [Up to 2 years after the treatment start]. Median, months (95% Confidence Interval). Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=64): 11.71 (7.92 to 14.55); Nab-paclitaxel + Gemcitabine (n=63): 10.94 (8.18 to 12.39).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Best Response [Up to the end of treatment on the average of 12 months]. Count Of Participants, Participants. Complete response: Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 1; Nab-paclitaxel + Gemcitabine (n=60): 0. Partial Response: Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 24; Nab-paclitaxel + Gemcitabine (n=60): 16. Stability: Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 20; Nab-paclitaxel + Gemcitabine (n=60): 26. Progression: Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 5; Nab-paclitaxel + Gemcitabine (n=60): 13. Death without any imagery: Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=62): 12; Nab-paclitaxel + Gemcitabine (n=60): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [up to 12 months after randomization]. Median, months (95% Confidence Interval). Nab-paclitaxel + Gemcitabine/FOLFIRI.3 (n=64): 5.72 (3.68 to 7.59); Nab-paclitaxel + Gemcitabine (n=63): 4.21 (2.43 to 6.01).
Papers 1
- Registry-listed results paperGemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients w… DOI 10.1016/j.ejca.2020.05.018↗
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.