CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Nitroglycerin 0.2 MG/HR +2 moredrug
Likely dose
Nitroglycerin 0.2 MG/HRfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01407107
NCT01407107Phase 1Completed
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Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer

University of Texas Southwestern Medical Center·interventional·Posted Aug 1, 2011·Updated Jan 14, 2021

In Brief

A Phase 1 clinical trial evaluating Nitroglycerin 0.2 MG/HR, Nitroglycerin 0.4 MG/HR, and 1 other intervention for Rectal Cancer. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesUnited States
CollaboratorsUS Department of Veterans Affairs

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 1, 2011
Enrollment StartJan 1, 2011
Primary CompletionOct 1, 2015
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.9 years ago

Interventions

Nitroglycerin 0.2 MG/HRdrug

0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr).

Nitroglycerin 0.4 MG/HRdrug

0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients.

Nitroglycerin 0.6 MG/HRdrug

0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.