Local excision for preserving the rectum in early rectal cancer

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).

This study is testing if a surgery called local excision can effectively treat early rectal cancer while helping patients keep their rectum.

Quick facts

• Study type: Observational
• Enrollment: 145 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Madrid)
• Trial ID: NCT05927584 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed infiltrating rectal adenocarcinoma or specific preoperative biopsy results indicating potential infiltration.

Not a fit: Patients with advanced rectal cancer or those not meeting the specific histological and imaging criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved quality of life for patients by minimizing the need for radical surgery.

How similar studies have performed: Previous studies have indicated that local excision can be a viable option for certain patients, but this specific approach is being evaluated for its effectiveness in a real-world setting.

Eligibility criteria

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 this trial is running

Madrid

• 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

Conditions: Rectal Cancer, Rectum Neoplasm, Early rectal cancer, Local excision, Total Mesorectal Excision, Organ preservation