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

NCT05040360 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Malignant Neoplasm in the Liver
  • Pancreatic Neuroendocrine Tumor
  • Stage I Pancreatic Neuroendocrine Tumor AJCC v8
  • Stage II Pancreatic Neuroendocrine Tumor AJCC v8
  • Stage III Pancreatic Neuroendocrine Tumor AJCC v8

Interventions

DRUG

Capecitabine

Given PO

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Heloisa P Soares · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Mexico
  • Uruguay

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040360 on ClinicalTrials.gov