Clinical trialPhase 2Terminated
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
- Outcome
- Stopped earlySlow Accrual (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2014
- Expected end
- June 2016
- Enrollment
- 7 participants
- Sites
- 1
- Primary outcomes
- Survival Rate at 18 Month
- Sponsor
- Other
- Results posted
- 2017-05-16
- Last update
- 16 May 2017
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Brief summary public domain (ClinicalTrials.gov)
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.
Detailed description public domain (ClinicalTrials.gov)
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B * Treatment will be administered on an outpatient basis. * Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel). * After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine . * Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Survival Rate at 18 Month [18 Month]. Count Of Participants, Participants. Folfirinox-ARM A (n=4): 2; Gemcitabine/Nab-Paclitaxel- Arm B (n=3): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Pathologic Complete Response Rate (pCR). [18 Months]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival Rate [Baseline, 5 Years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Serious and Non-Serious Adverse Events [Baseline, 28 Days]. Number, participants. Serious Adverse Events: Folfirinox-ARM A (n=4): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=3): 2. Other Adverse Events: Folfirinox-ARM A (n=4): 4; Gemcitabine/Nab-Paclitaxel- Arm B (n=3): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Surgical Morbidity Rate [within 30 days of surgery]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
30-day Post-operative Mortality Rate [30 Days]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Correlation of Biomarkers With PFS [2 Years]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Rate of Pathologic Downstaging [2 Years]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Local Control Rate [2 Years]. Folfirinox-ARM A (n=0): 0; Gemcitabine/Nab-Paclitaxel- Arm B (n=0): 0.