A Phase 2 interventional study of Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. in Cancer of Pancreas, Unresectable Pancreatic Cancer and Chemotherapy Effect, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Medical University of Silesia · Phase 2, Interventional, and Treatment
Primary goal:
Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.
Secondary targets:
STUDY PLAN Patients will receive initial mFOLFIRINOX (6 cycles) chemotherapy, followed by evaluation of the response to the treatment (imaging and laboratory testing) followed by SBRT, followed by mFOLFIRINOX chemotherapy.
In case of exclusion of disease progression after 10 weeks +/- 2 weeks after completion of SBRT, patients will be qualified to surgical treatment to attempt a radical surgical treatment.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
mFOLFIRINOX \> SBRT \> mFOLFIRINOX \> Surgical Intervention
Also known as: mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)
Improvement of the therapeutic index.
Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.
Time frame: 24 months.
Improvement of the overall survival.
Improvement of the overall survival by new treatment method.
Time frame: 60 months.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Medical University of Silesia