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NCT01068327 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT01068327: Completed Phase 1 study, sponsored by University of Nebraska.
NCT01068327 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01068327, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of stereotactic radiation therapy and nelfinavir mesylate when given together with gemcitabine hydrochloride, leucovorin calcium, and fluorouracil in treating patients with locally advanced pancreatic cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy and nelfinavir mesylate together with combination chemotherapy may kill more tumor cells.
Primary Outcome
Due to delayed toxicities attributable to radiotherapy, all toxicities observed within 1 month of surgery will be scored. Toxicity will be graded and tabled by dose levels.
Interventions
- RADIATION stereotactic body radiation therapy
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG gemcitabine hydrochloride
- DRUG nelfinavir mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2007-11-05 |
| Est. Completion | 2015-02-01 |
| Phase | Phase 1 |
What the finished NCT01068327 record still lists
NCT01068327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which stereotactic body radiation therapy is the first listed.
NCT01068327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01068327 about?
NCT01068327 is a clinical study titled "Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer". This phase I trial is studying the side effects and best dose of stereotactic radiation therapy and nelfinavir mesylate when given together with gemcitabine hydrochloride, leucovorin calcium, and fluorouracil in treating patients with locally advanced pancreatic cancer. Stereotactic radiation therap...
What is the current status of trial NCT01068327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2007-11-05. Estimated completion is 2015-02-01.
What interventions are being tested in trial NCT01068327?
The interventions under investigation include: stereotactic body radiation therapy (RADIATION), fluorouracil (DRUG), leucovorin calcium (DRUG), gemcitabine hydrochloride (DRUG), nelfinavir mesylate (DRUG).
Who is sponsoring clinical trial NCT01068327?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01068327's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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