Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
This study is looking at whether giving chemotherapy after surgery can help prevent pancreatic neuroendocrine tumors (pNETs) from coming back. If you have a high-risk pNET that has been removed by surgery, you might be able to join. The study is testing two chemotherapy drugs, capecitabine and temozolomide, which work by stopping cancer cells from growing or spreading. Researchers want to see if these drugs, given after surgery, can keep the cancer from returning for a longer time. The main goal is to measure how long people live without their cancer coming back.
- Study design
- This study is a Phase II trial that plans to enroll 141 participants. Participants will be randomly assigned to either receive chemotherapy or be observed without active treatment.
- What's involved
- Participants in the chemotherapy arm will take capecitabine and temozolomide orally for up to 4 cycles, with each cycle lasting 28 days. Participants in the observation arm will not receive active treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, participants will be followed up every 6 months for 3 years, and then annually until 5 years from when they joined the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05040360
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentSWOG Cancer Research NetworkGovernment-funded
~141 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:CapecitabineTemozolomide
At a glance
Recruiting sites
381 of 448 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-free survival (RFS)
Measured over From date of randomization to progression/recurrence or death from any cause, assessed up to 5 years
Conditions
Where it's being run
448 sites across 43 statesMinnesota45
Nevada42
Colorado37
California35
Washington33
Illinois24
Missouri21
Ohio18
Study leadership
- Heloisa P Soares · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria
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:
Gastrointestinal bleed
Jaundice
Gastrointestinal obstruction
Pain from primary tumor prior to surgical resection
Pancreatitis
2 points; primary pancreas tumor size \> 2 cm
1 point; Ki-67 3% to 20%
1 point; lymph node positivity = 1
6 points; Ki-67 21% to 55%
Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
Participants must have recovered from effects of surgery as determined by the treating investigator
Participants must be \>= 18 years old
Participants must have Zubrod performance status of 0-2
Participants must have a complete medical history and physical exam within 28 days prior to registration
Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration)
Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration)
Participants must be able to swallow pills
Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
Exclusion
Participants must not have unresected or unablated metastatic disease
Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
Participants must not have received somatostatin analogs after surgery
Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
Participants must not have known absorption issues that would limit the ability to absorb study agents
Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
Participants must not have active or uncontrolled infection
Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
What this trial measures
- Recurrence-free survival (RFS)From date of randomization to progression/recurrence or death from any cause, assessed up to 5 years
Distribution of RFS in each arm will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.