Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nebraska
About this trial
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.
Eligibility criteria
Qualifiers
Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
Adult, age > or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
ECOG Performance Status 0-2
Disqualifiers
Breast-feeding or pregnant
Active infection requiring IV antibiotics 7 days before enrollment
Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer
Prior history of rectal adenocarcinoma (RAC)
Trial design
Treatments tested in this trial
- BMX-001
Treatment groups
118 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Nebraska
Lead sponsor
BioMimetix JV, LLC
Collaborator
Source ClinicalTrials.gov