I. To evaluate recurrence-free survival (RFS) in participants with resected pancreatic neuroendocrine tumors (pNETs) randomized to treatment with capecitabine + temozolomide (CAPTEM) compared to observation only.
I. To evaluate overall survival (OS) in participants randomized to treatment with CAPTEM compared to observation only.
II. To evaluate the safety and tolerability of CAPTEM compared to observation only.
I. To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14 and temozolomide PO once daily (QD) on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo surveillance with no active treatment.
After completion of study treatment, patients are followed up every 6 months for 3 years and then annually until 5 years from randomization.
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