Clinical trialPhase 2Terminated
Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma
Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma
- Outcome
- Stopped earlyStudy was terminated due to low accrual. (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2012
- Enrollment
- 3 participants
- Sites
- 1
- Primary outcomes
- Estimate the R0/R1 Resection Rate
- Sponsor
- Other
- Results posted
- 2016-01-15
- Last update
- 15 January 2016
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Brief summary public domain (ClinicalTrials.gov)
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Estimate the R0/R1 Resection Rate [at time of surgery]. Number, participants. R0 resection status: Chemotherapy, Chemoradiation, Surgery (n=1): 1. R1 resection status: Chemotherapy, Chemoradiation, Surgery (n=1): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Radiographic Tumor Response [From enrollment to Surgery]. Number, participants. SD before chemoradiation: Chemotherapy, Chemoradiation, Surgery (n=3): 2. PD before chemoradiation: Chemotherapy, Chemoradiation, Surgery (n=3): 1. SD before surgery: Chemotherapy, Chemoradiation, Surgery (n=3): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Histopathologic Tumor Response [at the time of surgery]. Number, grade II responder. Chemotherapy, Chemoradiation, Surgery (n=1): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Recurrence: [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival: [2 years]. Number, days. Chemotherapy, Chemoradiation, Surgery (n=1): 256.