A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .
This study will be a prospective, interventional, open label, single arm, multiple center study. Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.
CHU de Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGCHU de Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGCentre Jean PERRIN - Clermont-Ferrand
Safety - Serious adverse events
Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria
Time frame: from Day 0 , up to 12 months
Efficacy - tumor response
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Objective tumor response rate according to RECIST 1.1
Time frame: Day 0 , up to 12 months
Efficacy - overall survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Overall survival
Time frame: Day 0 , up to 12 months
Efficacy - Progression-free survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to - Progression-free survival
Time frame: Day 0 , up to 12 months
Efficacy - Percentage of R0/R1 resected patients
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Percentage of R0/R1 resected patients
Time frame: Day 0 , up to 12 months
Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to percentage of patients with tumors that became surgically respectable after DaRT treatment
Time frame: Day 0 , up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clermont-Ferrand, France
Centre Georges François Leclerc Dijon
Dijon, France
NOT_YET_RECRUITINGCentre Georges François Leclerc Dijon
Dijon, France
NOT_YET_RECRUITINGCentre Georges François Leclerc Dijon
Dijon, France
NOT_YET_RECRUITINGCHU Grenoble Alpes
Grenoble, France
RECRUITINGHôpital Privé Mermoz - Lyon
Lyon, France
NOT_YET_RECRUITINGMarseille
Marseille, France
NOT_YET_RECRUITINGCHU Poitiers
Poitiers, France
NOT_YET_RECRUITING...and 2 more locations