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

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

PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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.
BANKING OBJECTIVE:
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.

Source: View full study details on ClinicalTrials.gov

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December 8, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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