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

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05726188

Collaborator

(none)

2,000

Enrollment

Locations

Anticipated Duration (Months)

83.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Stage I Colon Cancer	Procedure: Colonic resection

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Recurrence [5 years]
Number of patients who relapsed after curative resection

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Unit of Digestive and HPB Surgery, Henri Mordor University Hospital	Paris	France
2	Chirurgia dell'Apparato Digerente, IRCSS Giovanni Paolo II	Bari	Italy
3	Chirurgia Generale e Trapianto di Fegato, Azienda Ospedaliera Consorziale Policlinico di Bari	Bari	Italy
4	UO Chirurgia Generale 3, Spedali Civili 1	Brescia	Italy
5	Chirurgia Coloproctologica, AOU Cagliari	Cagliari	Italy
6	Chirurgia Generale, Ospedale di Cles	Cles	Italy
7	Chirurgia 1, Ospedale di Cona, AOUI Ferrara	Cona	Italy
8	Chirurgia Generale Colorettale, Ospedale degli Infermi	Faenza	Italy
9	UOS Chirurgia Colo-rettale, Ospedale San Gerardo	Monza	Italy
10	Chirurgia Endoscopica, AOUI Federico II	Napoli	Italy
11	UOC Oncologia Chirurgia Colorettale, Istituto Nazionale Tumori - IRCCS Fondazione Pascale	Napoli	Italy
12	Chirurgia Generale, AOU San Luigi Gonzaga	Orbassano	Italy
13	Chirurgia Generale 3, AOUI Padova	Padova	Italy
14	ASL TO 3 Presidio Pinerolo, Chirurgia	Pinerolo	Italy
15	Chirurgia Generale 2, Policlinico Gemelli	Roma	Italy
16	Policlinico TOR Vergata, Roma, Chirurgia Mininvasiva e dell'Apparato Digerente	Roma	Italy
17	UOC Chirurgia Generale 1, Policlinico Gemelli	Roma	Italy
18	Chirurgia Generale, Ospedale Santa Maria della Misericordia	Rovigo	Italy
19	Chirurgia Colorettale, IRCCS Humanitas	Rozzano	Italy
20	Chirurgia d'Urgenza e PS 3, AOU Città della Salute e della Scienza	Torino	Italy
21	Chirurgia Generale e Mininvasiva, Ospedale San Camillo	Trento	Italy
22	SC Clinica Chirurgia, Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
23	Unità di Chirurgia Colorettale, Clinica Santa Rita	Vercelli	Italy
24	Chirurgia Generale ed Epatobiliare, AOUI Verona	Verona	Italy	37134

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda Ospedaliera Universitaria Integrata Verona

ClinicalTrials.gov Identifier:

NCT05726188

Other Study ID Numbers:

CORE1

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona

prognosis

recurrence

Additional relevant MeSH terms:

Colonic Neoplasms

Recurrence

Study Results

No Results Posted as of Feb 17, 2023