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NCT01407107 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01407107: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT01407107 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407107, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether topical nitroglycerin in addition to 5-flourouracil and radiation therapy are effective in the treatment of operable rectal cancer.
Primary Outcome
DLT was defined as greater or equal to two instances of grade 3 toxicity, or a single event of grade 4-5 toxicity deemed probably or definitely related to the addition of transdermal neoadjuvant chemoradiation to the standard neoadjuvant chemoradiation
Interventions
- DRUG Nitroglycerin 0.2 MG/HR
- DRUG Nitroglycerin 0.4 MG/HR
- DRUG Nitroglycerin 0.6 MG/HR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT01407107 record still lists
NCT01407107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Nitroglycerin 0.2 MG/HR is the first listed.
NCT01407107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01407107 about?
NCT01407107 is a clinical study titled "Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer". The purpose of this study is to determine whether topical nitroglycerin in addition to 5-flourouracil and radiation therapy are effective in the treatment of operable rectal cancer.
What is the current status of trial NCT01407107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-01. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01407107?
The interventions under investigation include: Nitroglycerin 0.2 MG/HR (DRUG), Nitroglycerin 0.4 MG/HR (DRUG), Nitroglycerin 0.6 MG/HR (DRUG).
Who is sponsoring clinical trial NCT01407107?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01407107's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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