Early Phase 1 Colorectal Cancer Trial, Recruiting NCT03594630 Sponsor: M.D. Anderson Cancer Center Condition: Colorectal Cancer
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Early Phase 1 Colorectal Cancer Trial, Recruiting

NCT03594630
Recruiting Early Phase 1

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 who have been diagnosed with rectal adenocarcinoma (a specific type of rectal cancer), confirmed through laboratory testing of tissue.
  • People whose cancer is considered suitable for surgery with the goal of removing it completely (curative resection).
  • People whose rectal tumor is located no more than 12 cm from the opening of the anus, as measured by a camera examination of the bowel or an MRI scan.
  • People whose cancer has spread to nearby lymph nodes only within the area that would be treated by radiation.
  • People whose cancer can be measured or assessed through scans or clinical examination, as defined by the trial's guidelines.
  • People with a general health and activity level rated as 0, 1, or 2 on a standard scale used in cancer trials (ECOG scale), meaning ranging from fully active to capable of self-care but unable to carry out physical work (confirm with trial site).
  • People with Stage II or Stage III rectal cancer, assessed through a combination of physical examination, CT or PET/CT scans of the chest, abdomen and pelvis, and a pelvic MRI scan.
  • People who have no known medical reasons preventing them from receiving standard chemotherapy and radiation treatment to the pelvis (for example, no known deficiency in an enzyme called DPD that affects how certain chemotherapy drugs are processed).
  • People of childbearing potential who are willing to use adequate contraception during and after treatment, as directed by the treating medical team.
  • People who are willing to sign a written consent form to participate in the trial.
  • People who are willing to return to the trial site for all required study visits and assessments.

Who may not be able to join:

  • People who have been diagnosed with inflammatory bowel disease (a long-term condition causing inflammation in the digestive tract, such as Crohn's disease or ulcerative colitis).
  • People whose colorectal cancer has been identified as MSI-H (a specific genetic feature of the cancer) at the time of joining the trial.
  • People whose rectal cancer has come back after previous treatment (recurrent cancer).
  • People whose tumor is causing a blockage in the bowel that produces symptoms — though people who have already had a stoma (a surgical diversion of the bowel) created to manage this may still be considered eligible.
  • People who have previously had radiation treatment to the pelvic area.
  • People who are currently receiving active treatment for another separate invasive cancer.
  • People who are unwilling or unable to have a pelvic MRI scan.

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: George Chang, M.D. Anderson Cancer Center

Phone: 713-792-6940

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
Early Phase 1
Registry
ClinicalTrials.gov
Start date
13 March 2024
Est. completion
31 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall organ preservation rate; Local tumor regrowth rate; Time to surgery or death

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