Clinical trial · Interventional
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer
NCT01407107CI-TRIAL-00049427completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nitroglycerin 0.2 MG/HR | Drug | — | UNRESOLVED |
| Nitroglycerin 0.4 MG/HR | Drug | — | UNRESOLVED |
| Nitroglycerin 0.6 MG/HR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nitroglycerin
- description
- Dose escalation trial of Nitroglycerin
- interventionNames
- Drug: Nitroglycerin 0.2 MG/HR
- Drug: Nitroglycerin 0.4 MG/HR
- Drug: Nitroglycerin 0.6 MG/HR
Primary outcomes (1)
- measure
- The Number of Participants Experiencing Dose Limiting Toxicities (DLT)
- timeFrame
- Up to 4-6 weeks for each dosing cohort
- description
- 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
Secondary outcomes (1)
- measure
- Number of Participants With a Pathological Complete Response (pCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.