This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be >= 3% and =< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria
Gastrointestinal bleed
Participants must not have unresected or unablated metastatic disease
Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
Participants must not have received somatostatin analogs after surgery
Parallel
Capecitabine
DrugGiven PO
Temozolomide
DrugGiven PO
Recurrence-free survival (RFS)
Distribution of RFS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Overall survival (OS)
Distribution of OS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Incidence of adverse events
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
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SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator