Local excision for preserving the rectum in early rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to evaluate the effectiveness of local excision (LE) as a treatment for early-stage rectal cancer, specifically cT1N0M0 extraperitoneal adenocarcinoma. The study will collect data on patient demographics, tumor characteristics, surgical interventions, complications, and long-term outcomes related to rectal preservation. Patients will be monitored at various intervals post-surgery to assess the necessity of further treatments and the overall success of organ preservation. The goal is to determine the frequency of poor prognostic factors and complications associated with LE in real-world clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients age 18 years or older.
* Histologic proof of infiltrating rectal adenocarcinoma. or
* Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.

  1. Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .
  2. Ultrasonographic criteria: hipoecogenic rectal tumor invading the intermediate hyperecogenic layer (submucosal), but does not infiltrate the hypoecogenic outer layer (muscularis propia).
  3. Radiological criterio in MR: tumor invades the submucosal layer without infiltration of the rectal muscularis propia. The usual low signal submucosal image is substituted with an aberrant signal, meaning the loss of the zebra pattern in a normal rectal wall.
* Rectal neoplasm with an inferior limit no further than 2cm proximal to the anorectal verge, both in digital rectal examination and in radiology examinations, ideally magnetic resonance (MR).
* Rectal neoplasms up to 3 cm of major diameter.
* Clinical preoperative staging of cT1N0M0, based on endoscopy, MR, +/- endorectal ultrasound.
* Cases in which LE as exclusive treatment with curative intent is prescribed after MDT discusión, regardless of the approach both via flexible endoscopy and transanal endoscopic microsurgery and its variations.
* Neoplasms with low risk histologic criteria known preoperatively or lack of information regarding this aspect:

  1. Submucosal infiltration of less than 1000µm (sm1 in the Kikuchi classification) .
  2. Tumor budding absent.
  3. En bloc resection in patients with a previous endoscopic resection.
  4. Vascular, lymphatic and perineural invasión absent.
  5. Low histologic grade.

Exclusion Criteria:

* Patients younger than 18 years old.
* Rectal neoplasms different from adenocarcinoma.
* Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.
* Any other clinical stage other than cT1N0M0 (any T\>1, N+, or M+).
* Neoplasms larger than 3cm.
* Preoperatively demonstration of PPHF:

  1. Submucosal infiltration deeper than 1000µm (sm2 and sm3 in the Kikuchi classification)
  2. Tumor budding present.
  3. Piecemeal resection in cases with previous endoscopic resection.
  4. Vascular, lymphatic and perineural invasión presence.
  5. High histologic grade.
* Any patient with planned systemic treatment with RTQT combined with the LE after MDT discusión, regardless of the preoperative clinical or postoperative pathological stage.

Where it's running

• Hospital Universitario de la Princesa
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Rodrigo Tovar Perez, MD — Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Study coordinator: Rodrigo Tovar Perez, MD
• Email: triallorena@gmail.com
• Phone: +34915202200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using AI to classify rectal cancer during surgery

  This study is testing whether artificial intelligence can help doctors better identify rectal cancer during surgery for patients with larger polyps.

  Recruiting Mater Misericordiae University Hospital · Dublin, Ireland · NCT05793554

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.