ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases

Metastatic Colorectal Cancer Clinical Trial

— CLIMES  

Official title:

Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787197
• Other study ID #: CLIMES G-118 CIRCULATE-4
• Status: Recruiting
• Start date: January 9, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Maximiliano GELLI, MD
• Phone: +33(0)1 40 29 85 00
• Email: maximiliano.gelli[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

Description:

Blood collection times according to specific clinical situations:

• Standard approach

• Combined surgery

• Reverse strategy

• Two-stage hepatectomy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: June 30, 2027
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

The patient will be included if:

1. Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,

2. Is = 18 years of age,

3. Has histologically confirmed colorectal adenocarcinoma,

4. Has resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,

5. Has isolated CRLM that is deemed resectable or potentially resectable (extrahepatic metastases excluded, except infracentimetric non-specific lung lesions with largest diameter <1 cm and maximal number of =3) as judged by a multidisciplinary team meeting (based on CT scans of chest, abdomen, and pelvis [or MRI if CT not possible]),

6. Is eligible to surgical procedure,

7. Is fit for the chemotherapy-surgery combination treatment,

8. Is registered in a national health care system (Protection Universelle Maladie [PUMa] included).

Exclusion criteria

The patient will be excluded if:

1. Has definitively unresectable CLRM,

2. Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,

3. Has not resected primary rectal tumor (low and middle),

4. Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,

5. Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,

6. Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,

7. Blood samples cannot be collected if surgical procedure,

8. Is pregnant or breastfeeding,

9. Cannot be followed-up due to geographical, social, or psychic conditions,

10. Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,

11. Is under guardianship, curatorship, or under the protection of justice.

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon
France	Institut Bergonié	Bordeaux
France	CHU Lille - Hôpital Huriez	Lille
France	Centre Léon Bérard	Lyon
France	Hôpital Bichât Claude Bernard	Paris
France	Hôpital Cochin	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hôpital Saint Antoine	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital Haut Lévêque	Pessac
France	CHU de Poitiers	Poitiers
France	CHU Rouen	Rouen
France	CHU Strasbourg	Strasbourg
France	CHRU Tours	Tours
France	Hôpital Paul Brousse	Villejuif
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)	DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.	Up to 36 months
Secondary	Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.	EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.	Up to 4 years
Secondary	Overall survival (OS) n patients who undergo curative-intent resection of CRLM.	OS is defined as the time between inclusion and death. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.	Up to 4 years
Secondary	Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.	TFS is defined as the time from initial surgery until the first unresectable recurrence or death from any cause or the date of the last follow-up, at which point data are censored.	Up to 4 years
Secondary	Prognostic value of ctDNA	Prognostic value of ctDNA: post-operative ctDNA detection,; relative change in ctDNA level after curative resection of CRLM,; ctDNA in different subgroups of patients classified according to the type of surgical strategy (standard approach, combined surgery, reverse strategy, two-staged hepatectomy),	Up to 4 years
Secondary	Prognostic factor(s) for disease recurrence and survival.	Prognostic factor(s) for disease recurrence and survival in patients who undergo curative-intent resection of CRLM.	Up to 4 years
Secondary	Association between ctDNA and clinical features.	To identify the clinical, biological, and pathological factors associated with the ctDNA level.	Up to 4 years