Phase 2 Colorectal Cancer Trial, Recruiting NCT05939661 Sponsor: Osaka University Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT05939661
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 who have been fully informed about the study and have provided written consent to participate.
  • People whose rectal cancer has been confirmed as adenocarcinoma (a specific type of cancer) through tissue testing.
  • People whose cancer has not spread to distant parts of the body, and where complete surgical removal of the cancer is considered possible by their medical team.
  • People aged 20 years or older at the time of giving consent.
  • People with a physical fitness/activity level rated as 0 or 1 on a standard medical scale (ECOG); people aged 71 or older must have a rating of 0 only (confirm with trial site for what these ratings mean for your situation).
  • People whose rectal cancer has not been previously treated, and where the lower edge of the tumour is within 12 cm of the opening of the back passage.
  • People whose cancer is classified at a specific early stage (cT2N0M0) before treatment begins, based on specific imaging scan measurements of the tumour and nearby lymph nodes.
  • People whose recent blood and organ function test results (taken within 14 days before registering for the trial) meet specific minimum levels for blood cells, liver function, and kidney function, without having had blood transfusions or blood-boosting medications in the 14 days before those tests.

Who may not be able to join:

  • People who have had major surgery (other than a minor port insertion procedure) within the 4 weeks before starting the trial treatment.
  • People who have received any cancer treatment within the 4 weeks before starting the trial treatment.
  • People who have had radiation therapy within the 4 weeks before starting the trial treatment.
  • People with a serious existing lung condition, such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
  • People who have had a stent (a small tube) inserted into their colon.
  • People with serious ongoing health conditions such as heart failure, kidney failure, liver failure, a badly bleeding stomach ulcer, bowel paralysis, bowel obstruction, or poorly controlled diabetes.
  • People who currently have, or have had within the past 5 years, another active cancer elsewhere in the body (with some exceptions for very early-stage cancers that can be fully treated locally — confirm with trial site).
  • People who are pregnant, breastfeeding, have a positive pregnancy test, or are unwilling to use contraception during the trial.
  • People who test positive for Hepatitis B surface antigen or Hepatitis C antibodies.
  • People with a known HIV infection.
  • People whom the lead trial doctor considers unsuitable for the study for any other reason.

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 23 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

Phone: +81-6-6879-3251

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
Sponsor
Osaka University
Registry
ClinicalTrials.gov
Start date
25 May 2023
Est. completion
31 March 2026

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Pathological complete response (pCR)

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: 23 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