Colorectal Cancer Trial, Recruiting NCT05927584 Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT05927584
Recruiting Not Applicable

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:

  • Adults aged 18 years or older.
  • People who have been confirmed by tissue testing to have a type of rectal cancer called infiltrating rectal adenocarcinoma.
  • People whose tissue testing showed a rectal polyp or very early-stage cancer, but where additional tests (camera examination, ultrasound, or MRI scan) suggest a deeper infiltrating cancer may be present.
  • People whose rectal tumour is located within 2 centimetres of the lower end of the rectum, based on both physical examination and imaging scans (ideally an MRI).
  • People whose rectal tumour measures no more than 3 centimetres at its widest point.
  • People whose cancer has been staged as cT1N0M0 before surgery, meaning the cancer appears to be in an early stage with no spread to lymph nodes or other parts of the body.
  • People for whom a specialist multidisciplinary team has recommended a local surgical removal of the tumour as the sole treatment, whether performed through flexible camera techniques or transanal microsurgery.
  • People whose tumour, based on tissue analysis results available before surgery, shows low-risk features — such as shallow spread into the tissue layer beneath the lining, no tumour budding, no involvement of blood vessels, lymph vessels, or nerves, and a low-grade cancer appearance — or where this information is not yet available.

Who may not be able to join:

  • People under 18 years of age.
  • People whose rectal tumour is a type other than adenocarcinoma.
  • People whose tumour's lower edge is more than 2 centimetres from the lower end of the rectum, as measured on a preoperative MRI.
  • People whose cancer is at any stage other than cT1N0M0, meaning the cancer has grown deeper, spread to lymph nodes, or spread to other parts of the body.
  • People whose tumour is larger than 3 centimetres at its widest point.
  • People whose tissue testing before surgery has already shown higher-risk features — such as deeper spread into tissue layers, tumour budding present, incomplete removal in a previous procedure, cancer cells found in blood vessels, lymph vessels, or nerves, or a high-grade cancer appearance.
  • People for whom the specialist team has planned a combined treatment using radiation and chemotherapy alongside the local surgical removal, regardless of the cancer's stage before or after surgery.

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 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rodrigo Tovar Perez, MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Phone: +34915202200

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Registry
ClinicalTrials.gov
Start date
13 May 2024
Est. completion
1 March 2027

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Success rate

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: 19 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