Clinical Trial

SCARLET - Italian proSpeCtionAl obseRvationaL multicEntre Study on Treatment for recTal pT1 Cancer

Study acronym: SCARLET
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this prospective, observational, multicenter study is to evaluate the impact of adjuvant radiotherapy or chemoradiotherapy on disease-free survival (DFS) in patients with pathological T1 (pT1) rectal cancer presenting with at least one high-risk histological factor, such as deep submucosal invasion, poor differentiation, tumor budding, lymphovascular invasion, or positive resection margins, after local surgical or endoscopic excision, including Endoscopic Submucosal Dissection (ESD), Transanal Minimally Invasive Surgery (TAMIS), or Transanal Endoscopic Microsurgery (TEM). The study focuses on a specific patient population that has refused standard radical surgery with Total Mesorectal Excision (TME) because of its potential impact on quality of life and postoperative morbidity. The primary objective is to assess whether organ-preserving local treatment strategies can provide an effective alternative by evaluating long-term oncologic outcomes, quality of life, and colostomy-free survival.
Trial Details
NCT Number NCT07695519
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Rectal Cancer, Rectal Adenocarcinoma, Rectal Cancer Patients, Rectal Cancer, Radiotherapy
Enrollment 196 participants
Start Date 2026-09
Primary Completion 2029-09 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-10