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.
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).
No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease).
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.
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.
Cohort
Prospective
Not listed
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.
Disease-free survival at 1 year
Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 1 year from follow-up.
Disease-free survival at 5 years
Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 5 years from follow-up.
Local recurrence-free survival at 1 year
Time from the end of treatment to the documentation of local disease recurrence at 1 year.
Local recurrence-free survival at 3 years
Time from the end of treatment to the documentation of local disease recurrence at 3 years.
Nodal Recurrence Rate
ercentage of patients who develop regional lymph node recurrence during the follow-up period, as assessed by imaging modalities.
Distant Metastases Rate
Percentage of patients who develop distant organ metastases (outside the pelvis) during the follow-up period, confirmed by contrast-enhanced chest-abdomen-pelvis CT scan.
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