OncoMatch/Clinical Trials/NCT05040360
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Is NCT05040360 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Capecitabine and Temozolomide for metastatic malignant neoplasm in the liver.
Treatment: Capecitabine · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Neuroendocrine Tumor
Biomarker criteria
Required: MKI67 expression (Ki-67 >= 3% and <= 55%)
Ki-67 testing...must have been performed...and the result must be >= 3% and <= 55%
Disease stage
Required: Stage I, II, III (AJCC v8)
Stage I Pancreatic Neuroendocrine Tumor AJCC v8; Stage II Pancreatic Neuroendocrine Tumor AJCC v8; Stage III Pancreatic Neuroendocrine Tumor AJCC v8
Performance status
ZUBROD 0–2
Prior therapy
Must have received: surgery — resection of well-differentiated pNET
resected between 14 and 120 days prior to registration
Cannot have received: neoadjuvant therapy
Exception: Use of somatostatin analogs prior to surgery is permitted
Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
Cannot have received: somatostatin analog
Participants must not have received somatostatin analogs after surgery
Lab requirements
Blood counts
Leukocytes >= 3 x 10^3/uL; Absolute neutrophil count >= 1.5 x 10^3/uL; Platelets >= 100 x 10^3/uL
Kidney function
Serum creatinine <= 1.5x institutional ULN; Calculated creatinine clearance >= 50 ml/min
Liver function
Total bilirubin <= institutional ULN unless history of Gilbert's disease (then <= 5x ULN); AST and ALT <= 3x institutional ULN
Leukocytes >= 3 x 10^3/uL...Absolute neutrophil count >= 1.5 x 10^3/uL...Platelets >= 100 x 10^3/uL...Total bilirubin <= institutional ULN unless history of Gilbert's disease...AST and ALT <= 3 x institutional ULN...Serum creatinine <= 1.5 x institutional ULN...Calculated creatinine clearance >= 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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