Clinical trialPhase 1 / Phase 2Terminated
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
- Outcome
- Stopped earlyDue to slow accrual (Enrollment)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- June 2004
- Expected end
- October 2015
- Enrollment
- 24 participants
- Sites
- 2
- Primary outcomes
- Resectability After Chemoradiation
- Sponsor
- Other
- Results posted
- 2012-05-01
- Last update
- 5 December 2017
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Brief summary public domain (ClinicalTrials.gov)
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
Detailed description public domain (ClinicalTrials.gov)
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine. In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Resectability After Chemoradiation [7.5 weeks]. Number, participants. Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6 (n=24): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Overall Survival [up to 10 years since the start of the study].