Phase II Study of Capecitabine and Temozolomide After Surgery in Adults With High-Risk Pancreatic Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the effect of chemotherapy drugs capecitabine and temozolomide after surgery in patients with high-risk well-differentiated pancreatic neuroendocrine tumors. This phase II trial compares treatment with these drugs to observation only, aiming to see if chemotherapy can prevent or delay cancer recurrence and improve survival. The study also assesses the safety and tolerability of this chemotherapy combination and collects specimens for future research. Participants are randomly assigned to one of two groups. In the first group, patients take capecitabine twice daily on days 1 to 14 and temozolomide once daily on days 10 to 14, repeating this 28-day cycle for up to 4 cycles if there is no disease progression or unacceptable side effects. The second group undergoes surveillance without active treatment. After treatment or observation, all patients are followed every 6 months for 3 years, then annually until 5 years from randomization. During the study, participants will have regular medical exams and scans to monitor for cancer recurrence or progression. Researchers will assess recurrence-free survival as the primary outcome over up to 5 years, with overall survival and side effects also tracked. Safety evaluations are done up to 30 days after treatment completion. This long-term follow-up helps understand how well patients do after surgery with or without chemotherapy.

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors