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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 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 1 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983541
The ClinicalTrials.gov registry entry for NCT00983541 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT00983541 reports 0 study locations.
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.
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