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NCT05247905 · ClinicalTrials.gov registry record · Phase 2
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
A Phase 2 study of Metastatic Pancreatic Neuroendocrine Tumor and Unresectable Pancreatic Neuroendocrine Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 20
- Study locations
NCT05247905: Active Phase 2 study of Metastatic Pancreatic Neuroendocrine Tumor and Unresectable Pancreatic Neuroendocrine Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT05247905 is a Phase 2 study of Metastatic Pancreatic Neuroendocrine Tumor and Unresectable Pancreatic Neuroendocrine Carcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05247905, a Phase 2 study of Metastatic Pancreatic Neuroendocrine Tumor and Unresectable Pancreatic Neuroendocrine Carcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.
Primary Outcome
Progression free survival (PFS) will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio (HR) and median PFS will be estimated along with corresponding 95% confidence intervals.
Conditions Studied
Interventions
- DRUG Capecitabine
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Temozolomide
- DRUG Lutetium Lu 177 Dotatate
Study Locations (20)
California
- Tower Cancer Research Foundation - Beverly Hills
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- Cedars Sinai Medical Center - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- Bay Area Tumor Institute - Oakland
- Torrance Memorial Physician Network - Cancer Care - Torrance
- Epic Care Cyberknife Center - Walnut Creek
- BASS Medical Group - Lennon - Walnut Creek
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Rocky Mountain Cancer Centers - Centennial - Centennial
- The Women's Imaging Center - Denver
- Colorado Blood Cancer Institute - Denver
- Presbyterian - Saint Lukes Medical Center - Health One - Denver
- Rocky Mountain Cancer Centers-Midtown - Denver
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-02-16 |
| Est. Completion | 2033-10-01 |
| Phase | Phase 2 |
What the registry record for NCT05247905 still lists
NCT05247905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Metastatic Pancreatic Neuroendocrine Tumor appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05247905 names 20 study sites across 4 states, led by California, Colorado, Alaska.
Frequently Asked Questions
What is clinical trial NCT05247905 about?
NCT05247905 is a clinical study titled "Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors". This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and te...
What is the current status of trial NCT05247905?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2023-02-16. Estimated completion is 2033-10-01.
What conditions does trial NCT05247905 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT05247905?
The interventions under investigation include: Capecitabine (DRUG), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Temozolomide (DRUG), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT05247905?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05247905 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05247905's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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