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NCT05040360
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Phase 2 trial testing Capecitabine in Metastatic Malignant Neoplasm in the Liver in 141 participants. Currently enrolling.
31 March 2027
Quick facts
| Lead sponsor | SWOG Cancer Research Network |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 141 |
| Start date | 5 May 2022 |
| Primary completion | 31 March 2027 |
| Estimated completion | 31 March 2027 |
| Sites | 448 locations across Uruguay, United States, Mexico |
Drugs / interventions tested
- Capecitabine (capecitabine) — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Metastatic Malignant Neoplasm in the Liver — all drugs for Metastatic Malignant Neoplasm in the Liver →
- Pancreatic Neuroendocrine Tumor — all drugs for Pancreatic Neuroendocrine Tumor →
- Stage I Pancreatic Neuroendocrine Tumor AJCC v8 — all drugs for Stage I Pancreatic Neuroendocrine Tumor AJCC v8 →
- Stage II Pancreatic Neuroendocrine Tumor AJCC v8 — all drugs for Stage II Pancreatic Neuroendocrine Tumor AJCC v8 →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05040360
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Metastatic Malignant Neoplasm in the Liver
Currently open trials in the same condition.
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Other SWOG Cancer Research Network trials
Trials by the same sponsor.
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- NCT07278739 — Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams · NA · not yet recruiting
- NCT06769126 — Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM · Phase 2 · recruiting
- NCT07018869 — Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colore · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05040360 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SWOG Cancer Research Network
- Last refreshed: 15 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05040360.
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