Clinical trialEPhase 1Terminated
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer
- Outcome
- Stopped earlyPI left the institution; no further accruals (Other)
- Phase
- EPhase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 25 September 2017
- Expected end
- 31 July 2020
- Enrollment
- 25 participants
- Sites
- 1
- Primary outcomes
- Number of participants with adverse events as a measure of safety and tolerability
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 August 2020
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Brief summary public domain (ClinicalTrials.gov)
This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.
Detailed description public domain (ClinicalTrials.gov)
This pilot study will evaluate safety and tolerability of neoadjuvant chemotherapy followed by SBRT. Patients with locally advanced pancreatic cancer (LAPC) and borderline pancreatic inoperable cancer will be assigned to one of two treatment arms based upon performance status and physician's discretion. The two treatment arms are: Folfirinox or gemcitabine-nab paclitaxel (abraxane). There are no study drugs as all treatments are based on standard clinical pathways. After two cycles of treatment patients will be restaged with CT scans or imaging. If the tumor remains resectable, borderline, or unresectable without progression of disease, then the patient will proceed to SBRT. Follow-up visits will continue every three months for up to one year or until progression of disease.