Study Comparing Individualized Chemotherapy Selection Based on Tumor Profile to Standard Therapy in Patients Who Have Undergone Surgery for Pancreatic Cancer

Pancreatic cancer (pancreatic carcinoma) is a particularly aggressive form of cancer. Symptoms often do not appear until a late stage, so the disease is frequently diagnosed late. Even after surgery to remove the tumor, there is a risk that the cancer will return (recurrence). To reduce the risk of recurrence, patients often receive (adjuvant) chemotherapy after surgery.

Standard treatment following surgery includes two chemotherapy regimens: mFOLFIRINOX (a combination of four active ingredients: oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil) or gemcitabine with capecitabine. This treatment is intended to destroy any remaining cancer cells in the body and thus prevent the disease from recurring. To date, chemotherapy has been selected based on various medical criteria. A new approach to treatment selection involves genetic testing of the tumor. A specialized genetic test (“transcriptomic treatment-specific stratification signature”) is used to determine which chemotherapy regimen might be most suitable for each individual.

The goal of this Phase 3 study is to investigate whether chemotherapy selected on the basis of the genetic test is more effective than the current selection based on standard medical criteria. As part of the study, patients are randomly assigned to two groups. One group receives chemotherapy based on the results of this genetic test. The other group receives chemotherapy selected according to standard medical criteria. Both groups will receive an already approved standard chemotherapy regimen based on either oxaliplatin (mFOLFIRINOX) or gemcitabine/capecitabine. Therefore, no investigational drug or new therapy is being tested as part of the study. The study is open-label, meaning that both the medical staff and the patients know which group they have been assigned to. The primary endpoint of the study is disease-free survival at 76 months.

Eligible participants include women and men between the ages of 18 and 79 who have undergone surgical removal of pancreatic cancer and are eligible for subsequent chemotherapy. A tissue sample of the tumor must be available, and the patient must not have previously undergone radiation therapy or chemotherapy. Assignment to one of the groups must take place within 3–12 weeks after surgery.