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NCT05726188 Clinical Trial

Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer

Colon Cancer Clinical Trial

— CORE1  

Official title:
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05726188
Other study ID # CORE1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date September 30, 2023

Study information
Verified date July 2023
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact Corrado Pedrazzani, MD
Phone +39 0458126719
Email corrado.pedrazzani@univr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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: 1. Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection. 2. Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk. 3. Analyze the pattern of recurrence. 4. Analyze survival after recurrence.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Colon cancer up to recto-sigmoid junction - Histological diagnosis of adenocarcinoma - pT1 or pT2 according to AJCC staging system - Urgent and elective surgery - Curative resection - Minimally invasive or open surgery - Completion surgery included (Surgery for endoscopically resected pT1) Exclusion Criteria: - Rectal cancer - Adenoma with low- or high-grade dysplasia - Histology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamous carcinoma, etc) - Neo-adjuvant chemotherapy or radiotherapy - History of tumors other than CC

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Colonic resection
Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features

Locations
Country Name City State
France Unit of Digestive and HPB Surgery, Henri Mordor University Hospital Paris
Italy Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II Bari
Italy Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari Bari
Italy UO Chirurgia Generale 3, Spedali Civili 1 Brescia
Italy Chirurgia Coloproctologica, AOU Cagliari Cagliari
Italy Chirurgia Generale, Ospedale di Cles Cles
Italy Chirurgia 1, Ospedale di Cona, AOUI Ferrara Cona
Italy Chirurgia Generale Colorettale, Ospedale degli Infermi Faenza
Italy UOS Chirurgia Colo-rettale, Ospedale San Gerardo Monza
Italy Chirurgia Endoscopica, AOUI Federico II Napoli
Italy UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale Napoli
Italy Chirurgia Generale, AOU San Luigi Gonzaga Orbassano
Italy Chirurgia Generale 3, AOUI Padova Padova
Italy ASL TO 3 Presidio Pinerolo, Chirurgia Pinerolo
Italy Chirurgia Generale 2, Policlinico Gemelli Roma
Italy Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente Roma
Italy UOC Chirurgia Generale 1, Policlinico Gemelli Roma
Italy Chirurgia Generale, Ospedale Santa Maria della Misericordia Rovigo
Italy Chirurgia Colorettale, IRCCS Humanitas Rozzano
Italy Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza Torino
Italy Chirurgia Generale e Mininvasiva, Ospedale San Camillo Trento
Italy SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina Trieste
Italy Unità di Chirurgia Colorettale, Clinica Santa Rita Vercelli
Italy Chirurgia Generale ed Epatobiliare, AOUI Verona Verona

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Countries where clinical trial is conducted

France,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence Number of patients who relapsed after curative resection 5 years
Secondary Overall survival Percentage of patients alive 5 years after surgery 5 years
Secondary Cancer-related survival Percentage of patients who did not die from cancer-related causes 5 years
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