Phase III Study Comparing Gemcitabine Plus Nab-paclitaxel Switch Maintenance to Continued Modified FOLFIRINOX for Advanced Pancreatic Cancer

What this Trial Is About

Researchers are studying patients with advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The trial compares two chemotherapy approaches after an initial treatment period continuing the current chemotherapy regimen called mFOLFIRINOX or switching to a different chemotherapy combination of gemcitabine plus nab-paclitaxel. This phase III randomized trial aims to find out which approach helps patients live longer without disease progression after three months of initial chemotherapy. Participants first receive mFOLFIRINOX chemotherapy every two weeks for about 14 weeks, with at least 4 cycles required to continue in the trial. Those whose cancer has not worsened are then randomly assigned to one of two groups. One group continues mFOLFIRINOX, which includes oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil given by infusion every two weeks. The other group switches to gemcitabine and nab-paclitaxel, given on days 1, 8, and 15 in 28-day cycles. Treatment continues until the cancer progresses, side effects become unacceptable, the participant withdraws consent, or death. During the study, participants will have regular scans to monitor their cancer and assessments to track side effects, quality of life, and treatment response. Researchers will measure overall survival up to 48 months after randomization, along with progression-free survival, time until treatment stops, and other health outcomes. The trial includes ongoing evaluations of toxicity and quality of life to understand the impact of each treatment approach on patients. Participants remain under close medical supervision throughout the study period.

Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.