Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer (CORE1)

July 20, 2023 updated by: Azienda Ospedaliera Universitaria Integrata Verona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Unit of Digestive and HPB Surgery, Henri Mordor University Hospital
        • Contact:
          • Nicola De Angelis
  • Italy
      • Bari, Italy
        • Recruiting
        • Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II
        • Contact:
          • Michele Simone
      • Bari, Italy
        • Recruiting
        • Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari
        • Contact:
          • Donato Francesco Altomare
      • Brescia, Italy
        • Recruiting
        • UO Chirurgia Generale 3, Spedali Civili 1
        • Contact:
          • Riccardo Nascimbeni
      • Cagliari, Italy
        • Recruiting
        • Chirurgia Coloproctologica, AOU Cagliari
        • Contact:
          • Luigi Zorcolo
      • Cles, Italy
        • Recruiting
        • Chirurgia Generale, Ospedale di Cles
        • Contact:
          • Ciarleglio Francesco
      • Cona, Italy
        • Recruiting
        • Chirurgia 1, Ospedale di Cona, AOUI Ferrara
        • Contact:
          • Gabriele Anania
      • Faenza, Italy
        • Recruiting
        • Chirurgia Generale Colorettale, Ospedale degli Infermi
        • Contact:
          • Isacco Montroni
      • Monza, Italy
        • Recruiting
        • UOS Chirurgia Colo-rettale, Ospedale San Gerardo
        • Contact:
          • Marco Braga
      • Napoli, Italy
        • Recruiting
        • Chirurgia Endoscopica, AOUI Federico II
        • Contact:
          • Marco Milone
      • Napoli, Italy
        • Recruiting
        • UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale
        • Contact:
          • Delrio Paolo
      • Orbassano, Italy
        • Recruiting
        • Chirurgia Generale, AOU San Luigi Gonzaga
        • Contact:
          • Maurizio Degiuli
      • Padova, Italy
        • Recruiting
        • Chirurgia Generale 3, AOUI Padova
        • Contact:
          • Salvatore Pucciarelli
      • Pinerolo, Italy
        • Recruiting
        • ASL TO 3 Presidio Pinerolo, Chirurgia
        • Contact:
          • Andrea Muratore
      • Roma, Italy
        • Recruiting
        • Chirurgia Generale 2, Policlinico Gemelli
        • Contact:
          • Claudio Coco
      • Roma, Italy
        • Recruiting
        • Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente
        • Contact:
      • Roma, Italy
        • Recruiting
        • UOC Chirurgia Generale 1, Policlinico Gemelli
        • Contact:
          • Roberto Persiani
      • Rovigo, Italy
        • Recruiting
        • Chirurgia Generale, Ospedale Santa Maria della Misericordia
        • Contact:
          • Maurizio De Luca
      • Rozzano, Italy
        • Recruiting
        • Chirurgia Colorettale, IRCCS Humanitas
        • Contact:
          • Antonino SPINELLI
      • Torino, Italy
        • Recruiting
        • Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza
        • Contact:
          • Mauro Santarelli
      • Trento, Italy
        • Recruiting
        • Chirurgia Generale e Mininvasiva, Ospedale San Camillo
        • Contact:
          • Alberto Di Leo
      • Trieste, Italy
        • Recruiting
        • SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina
        • Contact:
          • Nicolò de Manzini
      • Vercelli, Italy
        • Recruiting
        • Unità di Chirurgia Colorettale, Clinica Santa Rita
        • Contact:
          • Mario Trompetto
      • Verona, Italy, 37134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with stage I colon cancer who underwent curative surgery at the participating centers between January 2010 and December 2019.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage I colon cancer
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 5 years
Number of patients who relapsed after curative resection
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Percentage of patients alive 5 years after surgery
5 years
Cancer-related survival
Time Frame: 5 years
Percentage of patients who did not die from cancer-related causes
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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