RecruitingNCT05927584

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

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


Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Enrollment

145 participants

Start Date

May 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether early-stage rectal cancer can be treated with local excision surgery (removing only the tumor, not the whole rectum) without additional radiation or chemotherapy, preserving the organ and quality of life. **You may be eligible if...** - You are 18 or older - You have confirmed or suspected early rectal cancer (stage T1, no lymph nodes affected, no spread) - Your tumor is small (up to 3 cm) and located in the lower part of the rectum - Your tumor has low-risk features on biopsy or imaging - Your surgical team recommends local excision as the treatment **You may NOT be eligible if...** - You are under 18 - Your tumor is larger than 3 cm or is not an adenocarcinoma - Your cancer has spread to lymph nodes or other organs - Your tumor shows high-risk features (deep invasion, poor grade, or involvement of blood/nerve vessels) - Your treatment plan includes radiation and chemotherapy alongside surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETransanal local excision

Transanal full thickness local excision


Locations(1)

Hospital Universitario de la Princesa

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05927584


Related Trials