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RESEARCH QUESTION

Does neoadjuvant FOLFIRINOX improve survival compared to adjuvant FOLFIRINOX in patients with resectable pancreatic cancer?

 

HYPOTHESIS

We hypothesize neoadjuvant FOLFIRINOX improves survival in patients with resectable pancreatic cancer.

 

STUDY DESIGN

The study is a randomized nationwide phase III superiority trial.

 

STUDY POPULATION

Patients with non-metastatic resectable pancreatic cancer on imaging and a good performance status.

 

INTERVENTION

Patients in the intervention arm (arm 1) start with four cycles of neoadjuvant FOLFIRINOX. After four cycles, restaging with a CT scan of the chest and abdomen is performed to rule out progressive disease. Patients without progression receive an additional four cycles of FOLFIRINOX. Restaging with a CT scan is repeated after eight cycles. Patients are eligible for a surgical exploration if they have non-metastatic disease. After resection, four cycles of adjuvant FOLFIRINOX are scheduled.

Patients in the comparator arm (arm 2) start with surgery. Adjuvant chemotherapy consists of 12 cycles of FOLFIRINOX. Treatment in the comparator arm is the current standard of care in the Netherlands for patients with resectable pancreatic cancer.

 

 

OUTCOME MEASURES

The primary outcome is overall survival (OS). Secondary outcomes are progression-free survival, toxicity from chemotherapy, surgical complications, resection rate, QALYs, cost-effectiveness ratio, and budget impact.

 

SAMPLE SIZE/DATA-ANALYSIS

Sample size calculation was performed for the primary endpoint of overall survival (OS). We estimated the OS in the adjuvant mFOLFIRINOX arm at 18 months. In order to detect a hazard ratio of 0.70 with 80% power (significance level a=0.05) 252 events needs to be observed. The number of events is expected to be reached with inclusion of 378 patients with an accrual period of 3 years. Cox proportional hazards is used to test for difference between the treatment arms.

 

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