About this trial
This trial looks at how well two treatments work for patients after surgery for high-risk pancreatic neuroendocrine tumors. The goal is to see if taking the drugs capecitabine and temozolomide can help stop the cancer from coming back. These drugs work in different ways to prevent tumor cells from growing and spreading. Researchers want to find out if this treatment can improve the time without cancer returning for patients.
The trial's ID number is NCT05040360. This is a Phase 2 trial, which means it is looking at how well the treatment works and its safety. The trial is regulated by the FDA, and about 141 participants are expected to join.
Who can join
This study is open to adults aged 18 and older, both men and women. Participants must have had surgery for a specific type of pancreatic tumor within the last 4 months. They also need a recent scan showing no spread of cancer to other areas. Some health requirements must be met, and no other active cancers are allowed, except for certain types that have been treated. The trial team will check eligibility for everyone.
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
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. In the first group, patients will take capecitabine and temozolomide for several weeks. In the second group, patients will not receive any active treatment but will be watched closely. Everyone will have check-ups every six months for three years after treatment.
Where
This trial is running at 446 locations in the United States. 380 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Alaska Breast Care and Surgery LLC
Anchorage, Alaska
Alaska Oncology and Hematology LLC
Anchorage, Alaska
Alaska Women's Cancer Care
Anchorage, Alaska
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska
Alegent Health Immanuel Medical Center
Omaha, Nebraska
Alegent Health Lakeside Hospital
Omaha, Nebraska
Allegiance Health
Jackson, Michigan
The first 8 of 446 sites are listed here. The registry record has the full list.