Actively Recruiting
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
60
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if adding metronidazole to standard therapy can decrease populations of Fusobacterium nucleatum (F. nucleatum) and other anaerobes (small organisms that cause infections) in participants with rectal cancer receiving neoadjuvant therapy, compared to neoadjuvant therapy alone.
CONDITIONS
Official Title
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with locally advanced rectal cancers (T3, T4, or N+ disease) planned for total neoadjuvant therapy
- No previous cytotoxic chemotherapy for the current tumor
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Adequate organ and marrow function as defined by blood counts and liver/kidney tests
- For chronic hepatitis B, viral load must be undetectable if on suppressive therapy
- For hepatitis C, must be treated and cured or have undetectable viral load if on treatment
- No unresectable distant metastases or unresectable primary tumors
- Participants with prior or concurrent malignancies that do not interfere with study assessments may participate
- Cardiac function assessed as New York Heart Association class 2B or better if history of cardiac disease or cardiotoxic treatment
- Women of childbearing potential and men must agree to use adequate contraception during the study
- Ability and willingness to sign informed consent
- Both English and non-English speakers eligible
You will not qualify if you...
- Chemotherapy or radiotherapy within 1 year before study entry
- Receiving any other investigational agents
- Brain metastases or unresectable metastases preventing standard proctectomy
- History of allergic reactions to metronidazole or related compounds
- Prior hypersensitivity to metronidazole or nitroimidazole derivatives
- Concurrent treatment with disulfiram
- Cockayne syndrome
- Uncontrolled intercurrent illness
- Psychiatric or social conditions limiting compliance
- Pregnant or breastfeeding women
- Cytotoxic chemotherapy within the last year due to microbiome effects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael G White, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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