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NCT05040360

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Recruiting now Phase 2 Last updated 15 December 2025
What this trial tests

Phase 2 trial testing Capecitabine in Metastatic Malignant Neoplasm in the Liver in 141 participants. Currently enrolling.

Timeline
5 May 2022
Primary endpoint
31 March 2027
31 March 2027

Quick facts

Lead sponsorSWOG Cancer Research Network
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment141
Start date5 May 2022
Primary completion31 March 2027
Estimated completion31 March 2027
Sites448 locations across Uruguay, United States, Mexico

Drugs / interventions tested

Conditions studied

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm in the Liver or Pancreatic Neuroendocrine Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211).
    Kunz PL, Graham NT, Catalano PJ, Nimeiri HS, et al · · 2023 · cited 222× · PMID 36260828 · DOI 10.1200/jco.22.01013
  2. Epidemiology of Neuroendocrine Neoplasms in the US.
    Dasari A, Wallace K, Halperin DM, Maxwell J, et al · · 2025 · cited 30× · PMID 40553474 · DOI 10.1001/jamanetworkopen.2025.15798
  3. Expert Consensus Practice Recommendations of the North American Neuroendocrine Tumor Society for the management of high grade gastroenteropancreatic and gynecologic neuroendocrine neoplasms.
    Eads JR, Halfdanarson TR, Asmis T, Bellizzi AM, et al · · 2023 · cited 29× · PMID 37184955 · DOI 10.1530/erc-22-0206
  4. Efficacy and safety of temozolomide-based regimens in advanced pancreatic neuroendocrine tumors: a systematic review and meta-analysis.
    Taherifard E, Bakhtiar M, Mahnoor M, Ahmed R, et al · · 2024 · cited 6× · PMID 38347461 · DOI 10.1186/s12885-024-11926-2
  5. Current Clinical Trial Landscape of Gastroenteropancreatic Neuroendocrine Tumors: A New Era of Landmark Trials.
    Peshin S, Modi S, Babakhanlou R, Arshad J. · · 2025 · cited 3× · PMID 41010726 · DOI 10.3390/jcm14186522

Verify or expand the search:

Other trials of Capecitabine

Trials testing the same drug.

Other recruiting trials for Metastatic Malignant Neoplasm in the Liver

Currently open trials in the same condition.

Other SWOG Cancer Research Network trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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