Using chemotherapy after surgery for high-risk pancreatic neuroendocrine tumors
Official title: Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors
Run by SWOG Cancer Research Network · NCT05040360 · Data updated 2026-11-12
This study tests if a combination of two chemotherapy drugs can help prevent cancer from coming back in people who have had surgery for high-risk pancreatic neuroendocrine tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 141 (estimated) |
| Sponsor | SWOG Cancer Research Network Research network |
| Drugs / interventions | Chemotherapy |
| Locations | 448 sites (Anchorage, Alaska and 447 other locations) |
| Status | Recruiting |
| Started | May 5, 2022 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT05040360 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with resected well-differentiated pancreatic neuroendocrine tumors who meet specific histological and imaging criteria.
✕Probably not a fit
Patients with metastatic disease or those whose tumors do not meet the specified histological criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of capecitabine and temozolomide in preventing cancer recurrence in patients who have undergone surgery for high-risk well-differentiated pancreatic neuroendocrine tumors. Participants are randomized into two groups: one receiving the chemotherapy regimen and the other undergoing observation without active treatment. The study aims to assess recurrence-free survival, overall survival, and the safety of the treatment. Additionally, specimens will be banked for future studies.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in patients with high-risk pancreatic neuroendocrine tumors.
How similar studies have gone: While similar approaches have been explored, this specific combination of capecitabine and temozolomide in this patient population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Where it's running
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States Recruiting -
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States Recruiting -
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States Recruiting -
Alaska Women's Cancer Care
Anchorage, Alaska, United States Recruiting -
Katmai Oncology Group
Anchorage, Alaska, United States Recruiting -
Providence Alaska Medical Center
Anchorage, Alaska, United States Recruiting
Show 44 more locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States Recruiting -
Kingman Regional Medical Center
Kingman, Arizona, United States Recruiting -
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States Recruiting -
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States Recruiting -
Banner University Medical Center - Tucson
Tucson, Arizona, United States Recruiting -
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States Recruiting -
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States Recruiting -
CARTI Cancer Center
Little Rock, Arkansas, United States Recruiting -
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States Recruiting -
PCR Oncology
Arroyo Grande, California, United States Recruiting -
Tower Cancer Research Foundation
Beverly Hills, California, United States Recruiting -
Keck Medicine of USC Buena Park
Buena Park, California, United States Recruiting -
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States Recruiting -
Mercy Cancer Center - Carmichael
Carmichael, California, United States Recruiting -
Mercy San Juan Medical Center
Carmichael, California, United States Recruiting -
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States Recruiting -
Keck Medicine of USC Huntington Beach
Huntington Beach, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
Keck Medicine of USC Koreatown
Los Angeles, California, United States Recruiting -
Los Angeles General Medical Center
Los Angeles, California, United States Recruiting -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
Cedars Sinai Medical Center
Los Angeles, California, United States Recruiting -
Mercy Cancer Center
Merced, California, United States Recruiting -
Providence Queen of The Valley
Napa, California, United States Recruiting -
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States Recruiting -
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States Recruiting -
Keck Medical Center of USC Pasadena
Pasadena, California, United States Recruiting -
Mercy Cancer Center - Rocklin
Rocklin, California, United States Recruiting -
Mercy Cancer Center - Sacramento
Sacramento, California, United States Recruiting -
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States Recruiting -
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States Recruiting -
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States Recruiting -
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States Recruiting -
Saint Joseph's Medical Center
Stockton, California, United States Recruiting -
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States Recruiting -
Woodland Memorial Hospital
Woodland, California, United States Recruiting -
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States Recruiting -
Saint Francis Cancer Center
Colorado Springs, Colorado, United States Recruiting -
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, United States Recruiting -
National Jewish Health-Main Campus
Denver, Colorado, United States Recruiting -
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States Recruiting -
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States Recruiting -
Mercy Medical Center
Durango, Colorado, United States Recruiting
+398 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Heloisa P Soares — SWOG Cancer Research Network
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.