Status:
COMPLETED
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is an open label, non-randomized, multi-cohort, dose escalation trial to evaluate the safety, tolerability, feasibility and maximum tolerated dose (MTD) of topical nitroglycerin in addition to 5-...
Eligibility Criteria
Inclusion
- Biopsy proven Rectal Adenocarcinoma
- Histological diagnosis of operable T3-4, or T1-4 node positive, M0 rectal adenocarcinoma using endorectal ultrasound and/or MRI in addition to Computed Tomography (CT) of the chest, abdomen and pelvis for pre-study staging Acceptable alternatives for systemic staging instead of CT chest , abdomen, pelvis are CT abdomen and pelvis plus a Chest X-ray or a PET/CT
- Ability to give informed consent and willingness to adhere to study protocol
- Age ≥ 18 years and otherwise eligible to receive medical care at the Dallas VA Medical Center.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hematological, hepatic and renal function defined as in protocol.
Exclusion
- Any condition that would hamper informed consent or ability to comply with the study protocol
- Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, decompensated congestive-heart failure, myocardial infarction within the last six months or ventricular arrhythmias requiring medication.
- Pregnant and lactating women.
- Patients taking Phosphodiesterase - 5 inhibitors (e.g. Sildenafil, Vardenafil or Tadalafil) and is unable to stop for the duration of the chemoradiotherapy.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01407107
Start Date
January 1 2011
End Date
October 1 2016
Last Update
January 14 2021
Active Locations (1)
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1
Dallas Veterans Affairs Medical Center
Dallas, Texas, United States, 75216