Phase 1 Colorectal Cancer Trial, Recruiting NCT07221058 Sponsor: Fox Chase Cancer Center Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT07221058
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:

  • A tissue sample (biopsy) must have confirmed a diagnosis of rectal adenocarcinoma (a specific type of rectal cancer).
  • The cancer must be at a specific stage — classified as T2-3, N0-1, M0 — meaning it has grown into but not beyond the rectal wall, with no or limited nearby lymph node involvement and no spread to other parts of the body. Staging is confirmed through MRI of the pelvis and a CT scan of the chest and abdomen (or a PET-CT scan as an alternative).
  • Participants must be willing to undergo MRI scans during the trial.
  • Participants must be 18 years of age or older.
  • Participants must have a general health status rated as ECOG 0 or 1, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
  • Participants must have an estimated life expectancy of at least 12 months.
  • Participants must have blood and organ function results within acceptable ranges, including adequate white blood cell counts, platelet counts, and liver function levels (confirm with trial site for specific values).
  • Participants must be medically able to tolerate the chemotherapy medicines used in the trial — capecitabine before the main treatment phase, and either FOLFOX, 5-FU, or capecitabine afterward.
  • Participants must be willing and able to sign an informed consent form. Translation services will be provided where possible to support inclusion of people from diverse backgrounds.

Who may not be able to join:

  • People who have already received treatment for rectal cancer.
  • People whose rectal cancer directly involves the anal canal (cancer that is close to but not inside the anal canal may still be considered).
  • People who are currently taking part in another clinical trial involving an experimental treatment.
  • People who have previously had radiation therapy to the pelvic area.
  • People who have had another cancer that was actively treated within the past 3 years, not including certain common skin cancers (non-melanoma skin cancer).
  • People with serious uncontrolled health conditions, such as an active infection, severe heart problems, uncontrolled heart rhythm issues, or mental health or social circumstances that could make it difficult to follow the trial requirements.
  • People with any condition or significant health problem that, in the treating doctor's judgment, would make the main radiation treatment unsafe to deliver.
  • People who are pregnant or breastfeeding.

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 15 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: Joshua Meyer, Fox Chase Cancer Center

Phone: 215-728-2667

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
Sponsor
Fox Chase Cancer Center
Registry
ClinicalTrials.gov
Start date
24 October 2025
Est. completion
1 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

MTD will be evaluated by monitoring the rate of dose limiting toxicities (DLTs) defined as acute Grade 2+ gastrointestinal toxicity probably or definitely related to radiation.; Feasibility of a rectal boost that targets at least 90% of the rectal planning tumor volume with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc.

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: 15 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