Clinical trial Recruiting at 381 sites Phase 2 Interventional Ages 18 and up

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.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment141 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionsChemotherapy
Locations448 sites (Anchorage, Alaska and 447 other locations)
StatusRecruiting
StartedMay 5, 2022
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedDecember 15, 2025
Trial IDNCT05040360 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.