Actively Recruiting
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment
Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2024-05-14
145
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
F
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead Sponsor
H
Hospital Alemão Oswaldo Cruz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Histologic proof of infiltrating rectal adenocarcinoma or preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with suspicion of infiltrating adenocarcinoma
- Tumor meeting endoscopic, ultrasonographic, or radiological criteria indicating early rectal cancer
- Tumor located no further than 2 cm proximal to the anorectal verge
- Tumor size up to 3 cm in major diameter
- Clinical preoperative staging of cT1N0M0 based on imaging and endoscopy
- Local excision prescribed as exclusive treatment with curative intent after multidisciplinary discussion
- Tumors with low-risk histologic criteria known preoperatively or lack of information, including submucosal infiltration less than 1000 µm, absence of tumor budding, en bloc resection if previously endoscopically resected, absence of vascular, lymphatic, or perineural invasion, and low histologic grade
You will not qualify if you...
- Patients younger than 18 years old
- Rectal neoplasms other than adenocarcinoma
- Tumors with inferior edge farther than 2 cm proximal to the anorectal verge on preoperative MRI
- Clinical stage other than cT1N0M0 (including any T greater than 1, N positive, or M positive)
- Tumors larger than 3 cm
- Presence of poor prognostic histologic factors preoperatively, including submucosal infiltration deeper than 1000 µm, tumor budding, piecemeal resection in previous endoscopic resection, vascular, lymphatic, or perineural invasion, or high histologic grade
- Patients planned for systemic treatment combined with radiochemotherapy and local excision after multidisciplinary discussion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario de la Princesa
Madrid, Spain, 28028
Actively Recruiting
Research Team
R
Rodrigo Tovar Perez, MD
CONTACT
C
Carlos Cerdán Santacruz, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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