Phase 2 Colorectal Cancer Trial, Recruiting NCT06569368 Sponsor: M.D. Anderson Cancer Center Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06569368
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with locally advanced rectal cancer (tumours that have grown through the bowel wall or spread to nearby lymph nodes) where the treatment team has decided to use a full course of treatment before surgery.
  • People who have not previously received chemotherapy drugs for this rectal cancer.
  • People aged 18 years or older.
  • People who are reasonably active and able to care for themselves, with a functional ability score within the acceptable range for this trial (confirm with trial site).
  • People whose blood counts and organ function (including liver and kidneys) meet the minimum levels required by the trial.
  • People with a history of hepatitis B who have an undetectable level of the virus while on suppressive treatment, if that treatment is needed.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable level of the virus.
  • People who have, or have had, another type of cancer, as long as that cancer or its treatment is unlikely to interfere with this trial's safety or results.
  • People with a history of heart disease or prior treatment with heart-affecting drugs, provided a doctor has assessed their heart function and it falls within the acceptable range for this trial.
  • People who are able to use an approved form of contraception throughout the trial and for the required period afterwards, as some drugs used in this trial may harm a developing baby.
  • People who are willing and able to read and sign a consent form agreeing to participate.
  • Both English-speaking and non-English-speaking people are eligible to participate.
  • People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.

Who may not be able to join:

  • People who have received chemotherapy or radiotherapy within the past year before entering the trial.
  • People who are currently taking part in another clinical trial involving an investigational treatment.
  • People whose cancer has spread to the brain or to other areas of the body in a way that cannot be surgically removed, meaning standard surgery would not be planned.
  • People who have had a serious allergic reaction to metronidazole or similar drugs, or to other medicines used in this trial.
  • People with a known history of hypersensitivity to metronidazole or related drugs in the same drug family.
  • People currently being treated with the drug disulfiram.
  • People with a condition called Cockayne syndrome.
  • People with a serious illness that is not currently under control (confirm specific details with trial site).
  • People with a mental health condition or personal circumstances that would make it difficult to follow the trial's requirements.
  • People who are currently pregnant, as one of the trial drugs may harm an unborn baby.
  • People who are currently breastfeeding, as the trial drug may affect nursing infants.
  • People who have received chemotherapy drugs within the past year, due to the known effects of chemotherapy on the environment inside tumours.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Michael G White, MD, M.D. Anderson Cancer Center

Phone: (713) 355-0897

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
10 July 2024
Est. completion
31 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and adverse events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov