Colorectal Cancer Trial, Recruiting NCT03465982 Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT03465982
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:

  • People who are over 18 years old
  • People whose rectal cancer has been confirmed by CT scan and MRI as a specific stage (a tumour that has grown through the bowel wall and may or may not have spread to nearby lymph nodes, but has not spread to distant parts of the body)
  • People whose tumour is located in the lower or middle part of the rectum, within 15 cm of the anal opening
  • People whose cancer has been confirmed by a tissue sample (biopsy) as a specific type called adenocarcinoma of the rectum
  • People whose doctors have determined they are suitable for surgery to remove the rectum using a technique called TME (this includes several types of rectal surgery)
  • People whose doctors have determined they are suitable for keyhole-style surgery, either standard or robot-assisted
  • People whose doctors have determined they are suitable for a combination of chemotherapy and radiation treatment before surgery
  • People who are able to sign a written consent form
  • People who are able to complete questionnaires in a language they speak fluently

Who may not be able to join:

  • People whose cancer has already spread to distant parts of the body
  • People whose cancer is a different type called squamous carcinoma of the anal canal
  • People who have additional bowel tumours that would require removal of more than one section of the bowel (note: a non-cancerous growth within the same surgical area would not necessarily prevent participation — confirm with trial site)
  • People with a history of psychiatric illness, addiction, or another medical condition that the trial doctor believes would prevent them from meeting trial requirements
  • People who are pregnant
  • People who are unable to complete the pre-surgery treatment (chemotherapy and radiation)
  • People who are unable to give free and informed consent
  • People who have previously had radiation treatment to the pelvic area
  • People with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
  • People with a hereditary bowel cancer condition
  • People who have had a previous cancer, other than certain low-risk skin cancers or certain types of thyroid cancer
  • People who are already participating in another clinical trial specifically about rectal cancer that covers similar topics to this trial

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
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

Phone: +390131206506

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
Not Applicable
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Registry
ClinicalTrials.gov
Start date
5 June 2018
Est. completion
5 June 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

pathologic 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: 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