Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

NCT05927584 | Recruiting

• 1 other identifier: HUP-23/5216
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE). A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure. The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer. The main question it aims to answer are: • How frequently does LE allow for rectum preservation? Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

Conditions

Rectal Cancer; Rectum Neoplasm

Keywords

Early rectal cancer; Local excision; Total Mesorectal Excision; Organ preservation

Outcome Measures

Primary Outcomes (1)

• Success rate

  Rate of patients with no need of Total Mesorectal Excision after follow-up

  36 months

Secondary Outcomes (4)

• Morbidity rate

  2 months

• Radicality of resection

  1 month

• Histological poor outcome predictor rate

  1 month

• Radical rescue surgery specimen quality

  1 month

Study Arms (1)

Local excision

* Patients older than 18 years * Diagnosis of rectal cancer * Inferior edge of the tumour not further than 2 cm above the anorectal ring * Clinical TNM staging T1N0M0

Procedure: Transanal local excision

Interventions

Transanal local excision PROCEDURE

Transanal full thickness local excision

Local excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with early stage rectal cancer, meaning clinical TNM staging cT1N0M0, programmed to receive Local Excision as an exclusive therapy according to each center´s standard practice.

You may qualify if:

• 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.
• 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 .
• Ultrasonographic criteria: hipoecogenic rectal tumor invading the intermediate hyperecogenic layer (submucosal), but does not infiltrate the hypoecogenic outer layer (muscularis propia).
• 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:
• Submucosal infiltration of less than 1000µm (sm1 in the Kikuchi classification) .
• Tumor budding absent.
• En bloc resection in patients with a previous endoscopic resection.
• Vascular, lymphatic and perineural invasión absent.

You may not qualify if:

• 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:
• Submucosal infiltration deeper than 1000µm (sm2 and sm3 in the Kikuchi classification)
• Tumor budding present.
• Piecemeal resection in cases with previous endoscopic resection.
• Vascular, lymphatic and perineural invasión presence.
• 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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Hospital Alemão Oswaldo Cruz: collaborator
• Hospital Universitario La Fe: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28028, Spain

RECRUITING

Related Publications (1)

• Tovar Perez R, Cerdan Santacruz C, Cano-Valderrama O, Jimenez Escovar F, Flor Lorente B, Perez RO, Garcia Septiem J. Local Excision for organ preservation in early REctal cancer with No Adjuvant treatment (LORENA Trial): prospective observational study protocol. Cir Esp (Engl Ed). 2024 Sep;102(9):506-512. doi: 10.1016/j.cireng.2024.04.013. Epub 2024 May 18.

  PMID: 38763491 DERIVED

Biospecimen

Retention: NONE RETAINED

Rectal cancer transanal local excision specimen

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rodrigo Tovar Perez, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

• Carlos Cerdán Santacruz, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY DIRECTOR

• Óscar Cano Valderrama, PhD

  Complejo Hospitalario Universitario de Vigo

  STUDY CHAIR

• Francisco Jiménez Escovar, PhD

  Hospital de Galdakao Usansolo

  STUDY CHAIR

• Blas Flor Lorente, PhD

  Hospital Politécnico Universitario la Fe

  STUDY CHAIR

• Javier García Septiem, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY CHAIR

• Rodrigo Oliva Pérez, PhD

  Hospital Alemão Oswaldo Cruz

  STUDY CHAIR

Central Study Contacts

Rodrigo Tovar Perez, MD

CONTACT

+34915202200; triallorena@gmail.com

Carlos Cerdán Santacruz, PhD

CONTACT

+34915202200; carlos.cerdan@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: May 13, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

ES (1)