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New treatment option for Rectal Adenocarcinoma
Official title Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
ClinicalTrials.gov ID: NCT06569368
What this study is testing
What is Metronidazole?
Metronidazole is an investigational medicine, being studied as a potential treatment for rectal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with locally advanced rectal cancers (T3, T4, or N+ disease) with decision to treat with total neoadjuvant therapy.
- No previous cycles of cytotoxic chemotherapy in management of the index tumor.
- Age ≥18 years. Because of dosing differences between pediatric and adult populations and the introduced variability with these regiments to the...
- ECOG performance status ≤2 (Karnofsky ≥60%,)
- Participants must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total...
You likely can't join if
- Participants who have had chemotherapy or radiotherapy within 1 year prior to entering the study.
- Participants who are receiving any other investigational agents.
- Participants with brain metastases or other unresectable metastases who would therefore not undergo standard of care proctectomy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metronidazole or other agents used in study.
- Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
- Concurrent treatment with disulfiram.
See the full eligibility criteria
- Participants with locally advanced rectal cancers (T3, T4, or N+ disease) with decision to treat with total neoadjuvant therapy.
- No previous cycles of cytotoxic chemotherapy in management of the index tumor.
- Age ≥18 years. Because of dosing differences between pediatric and adult populations and the introduced variability with these regiments to the study's primary outcomes, participants \<18 years of age, children are...
- ECOG performance status ≤2 (Karnofsky ≥60%,)
- Participants must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Participants with unresectable distant metastases are ineligible.
- Participants with unresectable primary tumors are ineligible.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of metronidazole on the developing human fetus are unknown. For this reason and because B2 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Ability to understand and the willingness to sign a written informed consent document.
- Both English and non-English-speaking participants will be eligible for inclusion in the trial.
- Participants who have had chemotherapy or radiotherapy within 1 year prior to entering the study.
- Participants who are receiving any other investigational agents.
- Participants with brain metastases or other unresectable metastases who would therefore not undergo standard of care proctectomy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metronidazole or other agents used in study.
- Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
- Concurrent treatment with disulfiram.
- Cockayne syndrome.
- Participants with uncontrolled intercurrent illness (Indicate clearly what type or extent).
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because metronidazole is a B2 agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.