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NOT YET RECRUITING

NCT07695519

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

196

Start Date

2026-09

Completion Date

2031-09

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Rectal Cancer Rectal Adenocarcinoma Rectal Cancer Patients Rectal Cancer, Radiotherapy

Inclusion Criteria: 1. Age 18 years or older. 2. Good performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1). 3. Primary tumor of the distal rectum (clinical T1) amenable to local endoscopic resection using Endoscopic Submucosal Dissection (ESD) or local surgical resection using Transanal Endoscopic Microsurgery (TEM) or Transanal Minimally Invasive Surgery (TAMIS). 4. High-risk pathological T1 rectal cancer meeting at least one of the following conditions: i) Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma. ii) Pathological submucosal invasion greater than 1000 micrometers. iii) Positive lymphatic invasion or positive venous invasion confirmed by immunohistochemistry. iv) Tumor budding grade 2 or 3. v) Positive lateral or vertical resection margin (tumor within 1 mm of the surgical margin) or non-assessable resection margin. 5. No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease). 6. Radiotherapy or chemoradiotherapy initiated within 12 weeks after local endoscopic or surgical resection. 7. No previous rectal resection (other than local excision) or pelvic irradiation for any malignancy. 8. Adequate organ function as assessed by the treating physician. 9. The treating surgeons have explained to the patient that the current standard of care is Total Mesorectal Excision (TME) with D2 lymph node dissection and the patient has declined this treatment. 10. Candidate for adjuvant chemoradiotherapy according to routine clinical practice. 11. Written informed consent provided. Exclusion Criteria: 1. Synchronous or metachronous malignancy diagnosed within the previous 5 years. 2. Infection requiring systemic treatment. 3. Requirement for continuous systemic treatment with corticosteroids or immunosuppressive agents. 4. Diagnosis of a hereditary colorectal cancer syndrome, including familial adenomatous polyposis or Lynch syndrome, or diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn disease. 5. Squamous cell carcinoma, neuroendocrine neoplasm, or mixed neuroendocrine-non-neuroendocrine neoplasm histology.

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy