Clinical trialPhase 2Terminated
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer
A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
- Outcome
- Stopped earlyThe principal investigator terminated the study due to inactivity and low enrollment (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- May 2011
- Expected end
- October 2013
- Enrollment
- 5 participants
- Sites
- 1
- Primary outcomes
- To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
- Sponsor
- Other
- Results posted
- 2018-03-09
- Last update
- 9 March 2018
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Brief summary public domain (ClinicalTrials.gov)
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy. [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy. [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria) [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Who Experienced Toxicity [2 years]. Count Of Participants, Participants. FOLFIRINOX (n=5): 2.