Phase 1 Colorectal Cancer Trial, Recruiting NCT04677413 Sponsor: University of Texas Southwestern Medical Center Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT04677413
Recruiting 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 are 18 years of age or older, of any gender, race, or ethnic background
  • People who are willing and able to sign a written consent form agreeing to take part
  • People who have been diagnosed with a specific type of rectal cancer called rectal adenocarcinoma
  • People whose cancer has grown into or through the rectal wall, or has spread to nearby lymph nodes, based on standard cancer staging guidelines
  • People who have not yet received any treatment for their rectal cancer
  • People who are reasonably active and able to care for themselves, based on a standard medical rating scale (confirm with trial site)
  • People whose recent blood test results show that their blood cells, liver, and kidneys are functioning within acceptable levels (confirm with trial site)
  • People who agree to use effective contraception — such as hormonal or barrier methods, or abstinence — starting from the first dose of treatment through to 90 days after the last dose. Women who become pregnant or think they might be pregnant during the trial must inform their treating doctor immediately

Who may not be able to join:

  • People whose cancer has spread to distant lymph nodes (such as those in the abdomen or groin) or to other parts of the body
  • People who have previously had radiation therapy to the pelvic area
  • People with serious uncontrolled health conditions, such as severe heart failure, unstable chest pain, irregular heart rhythms, or mental health conditions that could make it difficult to follow the trial requirements
  • People with mental health or social circumstances that would make it difficult to give informed consent or follow the trial's requirements
  • People who are currently pregnant or breastfeeding, due to potential risks to the baby

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 9 July 2026
Phase 1: approximately ~10% 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: Nina Sanford, MD, UT SOUTHWESTERN medical CENTRE

Phone: 12146458525

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 1
Registry
ClinicalTrials.gov
Start date
3 June 2021
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.

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: 9 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