Phase 1
N=13
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01407107 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Jan 2021
Primary outcome: Primary: The Number of Participants Experiencing Dose Limiting Toxicities (DLT) — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nitroglycerin 0.2 MG/HR (Drug); Nitroglycerin 0.4 MG/HR (Drug); Nitroglycerin 0.6 MG/HR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Dose Limiting Toxicities (DLT) |
0; 0; 0 | — |
| SECONDARY Number of Participants With a Pathological Complete Response (pCR) |
1; 0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01407107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.