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Clinical Trial Summary

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)


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03891472
Study type Interventional
Source Medical University of Silesia
Contact
Status Completed
Phase Phase 2
Start date January 1, 2017
Completion date July 31, 2019

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