Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors (S2104) is a recently activated National Clinical Trials Network randomized phase II trial designed to compare CAPTEM chemotherapy versus observation following resection of pNETs (see Figure 2). Patients with well-differentiated grade 2 or 3 (Ki-67 up to 55%) pNETS with a Zaidi score of ≥3 who underwent resection (or ablation) for either localized disease with or without up to five liver metastases are eligible for enrollment. Patients must be older than 18 years of age, have a Zubrod performance status of 0–2, and have adequate bone marrow function. Prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor is prohibited, with the exception of prior somatostatin analog use. Stratification factors for randomization are disease status before resection (metastatic versus nonmetastatic) and Zaidi score (≥6 versus <6 versus not applicable due to presence of metastatic disease).

FIGURE 2. Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Vs. Observation In High-Risk pNET: Swog S2104

The primary outcome is recurrence-free survival. Patients will be followed with cross-sectional imaging every 6 months for the first 3 years postresection and every 12 months for the next 2 years, for a total of 5 years of surveillance. To facilitate access to the trial, telehealth visits will be allowed in the first 4 months of enrollment for amenable visits. Correlative studies will be performed on banked blood and tissue. The S2014 trial will address a major knowledge gap in clinical practice, specifically the role of adjuvant therapy in patients undergoing resection for high-risk pNETs. If this study demonstrates that CAPTEM reduces recurrence, it will change the standard of care for this disease.

For more information, contact principal investigator of the trial, Heloisa Soares, MD, PhD, Heloisa.soares@hci.utah.edu.