Who is eligible for clinical trial NCT05254327?

Participants must meet the protocol's inclusion criteria for Rectal Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05254327 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-08-18

Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001 (NCT05254327)

A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Nebraska

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (16 items).

Location: Markey Cancer Center — Lexington, Kentucky

Age range: 18 Years

🧪 Interventions in This Study

BMX-001 (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 /dl, platelets ≥ 100,000 /dl (The use of transfusion or other intervention to achieve Hgb \> 9.0 g/dl is acceptable)
Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
Adequate renal function defined as follows:
Serum creatinine \< 1.5 mg/dl within 2 weeks prior to enrollment or 2)Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\]/\[(Serum Cr mg/dl) x (72)\], CCr female = 0.85 x (CrCl male) 8. Signed, written informed consent prior to completing any study specific procedures 9. Negative pregnancy test for women of child-bearing potential at the time of screening 10. Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment 11. Chest/Abdominal/Pelvic (CAP) CT/ pelvic MRI done within 8 weeks prior to randomization.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)
Prior history of pelvic radiotherapy for any other type of malignancy
Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.
Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be excluded unless they are on stable or decreasing corticosteroids dose at the time of randomization. BMX-001 Specific Exclusion Criteria (Subjects meeting any of the following criteria are ineligible for study entry)
Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg)
Active or history of postural hypotension and autonomic dysfunction within the past year
Known hypersensitivity to BMX-001
Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Markey Cancer Center — Lexington, Kentucky
University of Nebraska Medical Center — Omaha, Nebraska
UT Health San Antonio MD Anderson Cancer Center — San Antonio, Texas

📞 Contact the Study Coordinator

Phone: (402) 599-8711

Email: jessdelaney@unmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: Patients will receive 3 cycles of FOLFOX or 2 cycles of CAPOX and then be assigned to SCRT or LCCRT prior to randomization.

More studies in Rectal Cancer

Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management — Irvine, California
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer — Boston, Massachusetts
High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) — Tampa, Florida
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer — Phoenix, Arizona
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS) — Leuven,
A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. — New York, New York

Explore by condition: All Rectal Cancer clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗