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

Last updated: July 20, 2023
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Treatment

Colonic resection

Clinical Study ID

NCT05726188
CORE1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Rectal cancer
  • Adenoma with low- or high-grade dysplasia
  • Histology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamouscarcinoma, etc)
  • Neo-adjuvant chemotherapy or radiotherapy
  • History of tumors other than CC

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Colonic resection
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
September 30, 2023

Connect with a study center

  • Unit of Digestive and HPB Surgery, Henri Mordor University Hospital

    Paris,
    France

    Active - Recruiting

  • Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari

    Bari,
    Italy

    Active - Recruiting

  • Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II

    Bari,
    Italy

    Active - Recruiting

  • UO Chirurgia Generale 3, Spedali Civili 1

    Brescia,
    Italy

    Active - Recruiting

  • Chirurgia Coloproctologica, AOU Cagliari

    Cagliari,
    Italy

    Active - Recruiting

  • Chirurgia Generale, Ospedale di Cles

    Cles,
    Italy

    Active - Recruiting

  • Chirurgia 1, Ospedale di Cona, AOUI Ferrara

    Cona,
    Italy

    Active - Recruiting

  • Chirurgia Generale Colorettale, Ospedale degli Infermi

    Faenza,
    Italy

    Active - Recruiting

  • UOS Chirurgia Colo-rettale, Ospedale San Gerardo

    Monza,
    Italy

    Active - Recruiting

  • Chirurgia Endoscopica, AOUI Federico II

    Napoli,
    Italy

    Active - Recruiting

  • UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale

    Napoli,
    Italy

    Active - Recruiting

  • Chirurgia Generale, AOU San Luigi Gonzaga

    Orbassano,
    Italy

    Active - Recruiting

  • Chirurgia Generale 3, AOUI Padova

    Padova,
    Italy

    Active - Recruiting

  • ASL TO 3 Presidio Pinerolo, Chirurgia

    Pinerolo,
    Italy

    Active - Recruiting

  • Chirurgia Generale 2, Policlinico Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente

    Roma,
    Italy

    Active - Recruiting

  • UOC Chirurgia Generale 1, Policlinico Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Chirurgia Generale, Ospedale Santa Maria della Misericordia

    Rovigo,
    Italy

    Active - Recruiting

  • Chirurgia Colorettale, IRCCS Humanitas

    Rozzano,
    Italy

    Active - Recruiting

  • Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza

    Torino,
    Italy

    Active - Recruiting

  • Chirurgia Generale e Mininvasiva, Ospedale San Camillo

    Trento,
    Italy

    Active - Recruiting

  • SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste,
    Italy

    Active - Recruiting

  • Unità di Chirurgia Colorettale, Clinica Santa Rita

    Vercelli,
    Italy

    Active - Recruiting

  • Chirurgia Generale ed Epatobiliare, AOUI Verona

    Verona, 37134
    Italy

    Active - Recruiting

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