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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colon Cancer Stage I
• Colonic Neoplasms
• Recurrence

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