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

Recruiting

• Conditions: Colon Cancer Stage I; Colon Cancer
• Interventions: Procedure: Colonic resection

• Registration Number: NCT05726188
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage I colon cancer	Colonic resection	Patients aged 18 years or above with pT1 or pT2 N0 colon cancer (up to the recto-sigmoid junction) who underwent curative resection between January 2010 and December 2019

Primary Outcome Measures

Name	Time	Method
Recurrence	5 years	Number of patients who relapsed after curative resection

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Percentage of patients alive 5 years after surgery
Cancer-related survival	5 years	Percentage of patients who did not die from cancer-related causes

Trial Locations

Locations (24)

Chirurgia Generale Colorettale, Ospedale degli Infermi; 🇮🇹 Faenza, Italy

Chirurgia Generale 3, AOUI Padova; 🇮🇹 Padova, Italy

UOC Chirurgia Generale 1, Policlinico Gemelli; 🇮🇹 Roma, Italy

UO Chirurgia Generale 3, Spedali Civili 1; 🇮🇹 Brescia, Italy

Chirurgia 1, Ospedale di Cona, AOUI Ferrara; 🇮🇹 Cona, Italy

Chirurgia Endoscopica, AOUI Federico II; 🇮🇹 Napoli, Italy

Chirurgia Generale, Ospedale Santa Maria della Misericordia; 🇮🇹 Rovigo, 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

Unit of Digestive and HPB Surgery, Henri Mordor University Hospital; 🇫🇷 Paris, France

Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II; 🇮🇹 Bari, Italy

Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy

UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale; 🇮🇹 Napoli, Italy

SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina; 🇮🇹 Trieste, Italy

Unità di Chirurgia Colorettale, Clinica Santa Rita; 🇮🇹 Vercelli, Italy

Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente; 🇮🇹 Roma, Italy

Chirurgia Generale, AOU San Luigi Gonzaga; 🇮🇹 Orbassano, Italy

ASL TO 3 Presidio Pinerolo, Chirurgia; 🇮🇹 Pinerolo, Italy

Chirurgia Generale ed Epatobiliare, AOUI Verona; 🇮🇹 Verona, Italy

Chirurgia Coloproctologica, AOU Cagliari; 🇮🇹 Cagliari, Italy

Chirurgia Generale, Ospedale di Cles; 🇮🇹 Cles, Italy

UOS Chirurgia Colo-rettale, Ospedale San Gerardo; 🇮🇹 Monza, Italy

Chirurgia Generale 2, Policlinico Gemelli; 🇮🇹 Roma, Italy

Chirurgia Colorettale, IRCCS Humanitas; 🇮🇹 Rozzano, Italy