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NCT00288093 · ClinicalTrials.gov registry record · Phase 1
3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase 1 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00288093: Completed Phase 1 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT00288093 is a Phase 1 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer AJCC v6 and v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00288093, a Phase 1 study of Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer AJCC v6 and v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of 3-AP when given together with radiation therapy in treating patients with stage III pancreatic cancer that cannot be removed by surgery. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may kill more tumor cells.
Primary Outcome
MTD will be the dose at which 1 or fewer patients (less than or equal to 1/6) experiences a DLT during the treatment cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will be defined as greater than or equal to Grade 3 non-hematologic or greater than or equal to Grade 4 hematologic adverse event with the following exceptions: greater than or equal to Grade 3 nausea and greater than or equal to Grade 3 vomiting that improves with antiemetic therapy greater
Conditions Studied
Interventions
- RADIATION 3-Dimensional Conformal Radiation Therapy
- DRUG Triapine
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-12-20 |
| Est. Completion | 2012-12-28 |
| Phase | Phase 1 |
What the finished NCT00288093 record still lists
NCT00288093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 99,465-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which 3-Dimensional Conformal Radiation Therapy is the first listed.
NCT00288093 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00288093 about?
NCT00288093 is a clinical study titled "3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery". This phase I trial is studying the side effects and best dose of 3-AP when given together with radiation therapy in treating patients with stage III pancreatic cancer that cannot be removed by surgery. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. R...
What is the current status of trial NCT00288093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-12-20. Estimated completion is 2012-12-28.
What conditions does trial NCT00288093 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT00288093?
The interventions under investigation include: 3-Dimensional Conformal Radiation Therapy (RADIATION), Triapine (DRUG).
Who is sponsoring clinical trial NCT00288093?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00288093 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00288093's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma 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.
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