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NCT05726188
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer
Conditions: Colon Cancer Stage I, Colon Cancer
Sex: All
Ages: 18 Years – N/A
Enrollment: 2000
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Location: France
Summary
Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia.
Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients.
Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1.
However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery.
Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification.
Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1.The present multicentric retrospective study aims to:Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.Analyze the pattern of recurrence.Analyze survival after recurrence.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsColon cancer up to recto-sigmoid junctionHistological diagnosis of adenocarcinomapT1 or pT2 according to AJCC staging systemUrgent and elective surgeryCurative resectionMinimally invasive or open surgeryCompletion surgery included (Surgery for endoscopically resected pT1)Exclusion Criteria:Rectal cancerAdenoma with low- or high-grade dysplasiaHistology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamous carcinoma, etc)Neo-adjuvant chemotherapy or radiotherapyHistory of tumors other than CC
Source: ClinicalTrials.gov (NCT05726188). StuddyBuddy aggregates publicly available trial information.