Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer

Completed · Phase 1

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01407107

Run by

University of Texas Southwestern Medical Center

People needed

13

Starts

2011-01-01

Expected to finish

2016-10-01

Last updated by the study team

2021-01-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dallas Veterans Affairs Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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