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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.

Phase 2RecruitingSWOG Cancer Research NetworkNCT05040360Data as of May 2026

Treatment: Capecitabine · TemozolomideThis 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.

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Extracted 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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