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NCT00983541 · ClinicalTrials.gov registry record · Phase 2
Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma
A Phase 2 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00983541: Clinical Trial Phase 2 study, sponsored by University of Utah.
NCT00983541 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983541, a Phase 2 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible. Primary Objectives * To establish a preliminary assessment whether toxicity rates are acceptable in patients with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a regimen of gemcitabine every two weeks and continuous fluorouracil (5-FU) given concurrently with external beam radiation therapy to a total dose of 45 gray(Gy), followed by a brachytherapy or Stereotactic Body Radiation Therapy(SBRT) boost. Secondary Objectives * To evaluate the overall survival rate, progression free survival rate, tumor response rate, local control rate and the rate of distant metastases following gemcitabine and continuous 5-FU concurrent with radiation therapy in patients with locally advanced intra or extrahepatic cholangiocarcinoma. * To evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma become resectable following gemcitabine and radiation therapy.
Interventions
- DRUG Gemcitabine
- DRUG Fluorouracil (5-FU)
- RADIATION Brachytherapy or SBRT (Stereotactic body radiation therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
Why NCT00983541 stopped before completion
NCT00983541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT00983541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983541 about?
NCT00983541 is a clinical study titled "Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma". OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible. Primary Objectives * To establish a preliminary assessment whether toxicity rates are acceptable in patients with locally ad...
What is the current status of trial NCT00983541?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00983541?
The interventions under investigation include: Gemcitabine (DRUG), Fluorouracil (5-FU) (DRUG), Brachytherapy or SBRT (Stereotactic body radiation therapy) (RADIATION).
Who is sponsoring clinical trial NCT00983541?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00983541's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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