Chemotherapy Effect Clinical Trial
Official title:
Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer
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:
- Survival rate (OS) assessment in patients treated with mFOLFIRINOX + SBRT
- Assessment of quality of life using questionnaires: EQ-5D, EORTC (QLQ-C30) and
pancreatic cancer-specific QLQ PAS module 26
- Early toxicity <3 months after completion of SBRT treatment.
- Percentage of local control (1-year)
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.
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