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NCT01376453 · ClinicalTrials.gov registry record · Phase 1
Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01376453: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01376453 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376453, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The main purpose of this study is to find the maximum tolerable dose of sorafenib when administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about whether these drugs, along with radiation, can help people with rectal cancer when given before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration (FDA) for use in people with rectal cancer. The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of the study, the investigators will attempt dose escalation of sorafenib in combination with standard infusional 5-FU and external beam at standard doses. Clinical staging should be done by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile and efficacy.
Primary Outcome
To determine maximally tolerated dose of sorafenib when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinoma
Interventions
- DRUG 5-Fluorouracil (5-FU)
- RADIATION Radiation
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT01376453 record still lists
NCT01376453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which 5-Fluorouracil (5-FU) is the first listed.
NCT01376453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376453 about?
NCT01376453 is a clinical study titled "Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer". The main purpose of this study is to find the maximum tolerable dose of sorafenib when administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about whether these drugs, along with radiation, can help people with rectal cancer when given before surgery. 5-FU and radiat...
What is the current status of trial NCT01376453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-06. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01376453?
The interventions under investigation include: 5-Fluorouracil (5-FU) (DRUG), Radiation (RADIATION), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01376453?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376453's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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