NCT03891472

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Cancer of Pancreas
• Unresectable Pancreatic Cancer
• Chemotherapy Effect
• SBRT

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-03-27
• Last updated: 2019-11-13

Locations

1 site across 1 country: Poland