NCT05040360

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

Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Malignant Neoplasm in the Liver
• Pancreatic Neuroendocrine Tumor
• Stage I Pancreatic Neuroendocrine Tumor AJCC v8
• Stage II Pancreatic Neuroendocrine Tumor AJCC v8
• Stage III Pancreatic Neuroendocrine Tumor AJCC v8

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2022-05-05
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-09-10
• Last updated: 2025-12-15

Locations

448 sites across 3 countries: United States, Mexico, Uruguay

Regulatory

• FDA-regulated drug study