OncoMatch/Clinical Trials/NCT06569368
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
Is NCT06569368 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Metronidazole for rectal adenocarcinoma.
Treatment: Metronidazole — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
No previous cycles of cytotoxic chemotherapy in management of the index tumor.
Cannot have received: chemotherapy or radiotherapy
Participants who have had chemotherapy or radiotherapy within 1 year prior to entering the study.
Cannot have received: cytotoxic chemotherapy
Participants who received cytotoxic chemotherapy within the last year are excluded from this study given known associations between chemotherapy administration and alterations in the tumoral microbiome.
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL
Kidney function
creatinine ≤ institutional ULN
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
Cardiac function
clinical risk assessment of cardiac function using the New York Heart Association Functional Classification; class 2B or better
absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN ... cardiac disease ... should have a clinical risk assessment ... class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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