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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.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06569368Data as of May 2026

Treatment: MetronidazoleTo 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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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