Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
This trial is active, not recruiting.
|Sponsor||University of Texas Southwestern Medical Center|
|Collaborator||VA Office of Research and Development|
|Start date||January 2011|
|End date||March 2017|
|Trial size||24 participants|
|Trial identifier||NCT01407107, STU 122010-172|
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.
|Intervention model||single group assignment|
Dose escalation trial of Nitroglycerin
Maximum tolerated dose (MTD)
time frame: 4-6 weeks
Pathological complete response (pCR)
time frame: Time of surgery (~ 6-9 wks) following the completion of neoadjuvant therapy
Male or female participants from 18 years up to 90 years old.
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.
|Official title||Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer|
|Principal investigator||Jonathan Dowell, MD|
|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-flourouracil and radiation therapy for neo-adjuvant treatment of, T3-T4 or clinically node positive, operable rectal cancer. Patients that would otherwise be eligible for concurrent neo-adjuvant chemotherapy with continuous infusion 5-FU, for locally advanced operable rectal cancer, will be assigned to 4 sequential cohorts of 4 different dose levels of nitro glycerin patches (0.2; 0.4; 0.6 and 0.8mg/hr). Each cohort will consist of 3 patients. All patients will receive radiation therapy, 45-50 Gy in 25-28 fractions to the pelvis along with continuous infusion 5-FU 225mg/M2 for the duration of the radiation therapy. The radiation therapy will be planned and delivered as per institutional standard of care for the Dallas VAMC radiation oncology department.|
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