A Phase 2 interventional study of Capecitabine and Temozolomide in Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor and Stage I Pancreatic Neuroendocrine Tumor AJCC v8, sponsored by SWOG Cancer Research Network. Recruiting at 448 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
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.
Participants with localized resected pNETS must have a Zaidi score of >= 3 derived by the following factors and points:
1 point; symptomatic tumor defined as one of the following:
Exclusion Criteria:
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Capecitabine · Drug: Temozolomide
Patients undergo surveillance with no active treatment.
Given PO
Also known as: Ro 09-1978/000, Xeloda
Given PO
Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
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.
Time frame: From date of randomization to progression/recurrence or death from any cause, assessed up to 5 years
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.
Time frame: From date of registration to date of death due to any cause, assessed up to 5 years
Incidence of adverse events
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 30 days after completion of treatment
Showing the first 100 of 448 sites across 3 countries.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SWOG Cancer Research Network