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

NCT07695519 | Not Yet Recruiting

• 1 other identifier: 27321
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Rectal Adenocarcinoma; Rectal Cancer Patients; Rectal Cancer, Radiotherapy

Keywords

pT1 Rectal Cancer; Local Excision; Transanal Minimally Invasive Surgery; TAMIS; Transanal Endoscopic Microsurgery; TEM; Endoscopic Submucosal Dissection; ESD; Adjuvant Radiotherapy; Adjuvant Chemoradiotherapy; High-Risk Factors; Organ Preservation

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-Free Survival (DFS)

  Percentage of patients who remain alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at three years from the start of follow-up.

  3-years

Secondary Outcomes (16)

• Disease-free survival at 1 year

  1 year

• Disease-free survival at 5 years

  5 years

• Local recurrence-free survival at 1 year

  1 year

• Local recurrence-free survival at 3 years

  3 years

• Local recurrence-free survival at 5 years

  5 years

Other Outcomes (2)

• Nodal Recurrence Rate

  Up to 5 years after completion of adjuvant treatment.

• Distant Metastases Rate

  Up to 5 years after completion of adjuvant treatment.

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

dult patients with high-risk pathological T1 (pT1) rectal cancer who have undergone local endoscopic resection using Endoscopic Submucosal Dissection (ESD) or local surgical resection using Transanal Endoscopic Microsurgery (TEM) or Transanal Minimally Invasive Surgery (TAMIS). The study population specifically includes patients who have declined standard treatment with Total Mesorectal Excision (TME) and who subsequently receive adjuvant radiotherapy or chemoradiotherapy according to routine clinical practice following multidisciplinary team evaluation.

You may qualify if:

• Age 18 years or older.
• Good performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1).
• 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).
• 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.
• No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease).
• Radiotherapy or chemoradiotherapy initiated within 12 weeks after local endoscopic or surgical resection.
• No previous rectal resection (other than local excision) or pelvic irradiation for any malignancy.
• Adequate organ function as assessed by the treating physician.
• 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.
• Candidate for adjuvant chemoradiotherapy according to routine clinical practice.
• Written informed consent provided.

You may not qualify if:

• Synchronous or metachronous malignancy diagnosed within the previous 5 years.
• Infection requiring systemic treatment.
• Requirement for continuous systemic treatment with corticosteroids or immunosuppressive agents.
• 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.
• Squamous cell carcinoma, neuroendocrine neoplasm, or mixed neuroendocrine-non-neuroendocrine neoplasm histology.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

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

• Giuditta Chiloiro, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuditta Chiloiro, MD, Phd

CONTACT

06-30154981; giuditta.chiloiro@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

IT (1)