Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers

Terminated

• Conditions: Cirrhosis; Neoplasms
• Interventions: Other: Current care study

• Registration Number: NCT04179773
• Lead Sponsor: University Hospital, Lille

Brief Summary

Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs.

Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies.

The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy.

The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer.

Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients' outcomes with a control group of matched non-cirrhotic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-24
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Follow-up for the following cancers: upper digestive sphere (stomach, esophagus, pancreas, bile ducts), colorectal, ENT
• Theoretical indication of conventional chemotherapy based on 5FU, anthracyclins, platinum salts, gemcitabin, taxans, irinotecan or antiangiogenic drugs, anti-EGFR or anti-HER 2 therapies, according to management guidelines
• Beneficiary of a social security system
• Dated and signed non-opposition consent

Exclusion Criteria

• Other concomitant primary cancer
• Pregnant women
• Patients under guardianship, curatorship or justice protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhotic patients	Current care study	Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging)
Non-cirrhotic patients	Current care study	Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging)

Primary Outcome Measures

Name	Time	Method
Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis	before the chemotherapy initiation, within 45 days of multidisciplinary board

Secondary Outcome Measures

Name	Time	Method
Survival time	the date of death, the date of last news or the point date (12 months).	Survival time defined as the difference between the date of initiation of chemotherapy,
Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy	within 45 days of multidisciplinary board.
Frequency of chemotherapy side effects according to CTCAE version 5.0 classification in cirrhotic patients who have received chemotherapy	Up to 5 years after chemotherapy
Progression-free survival time	the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months).	Progression-free survival time defined as the difference between the date of initiation of chemotherapy, the date of progression or death, the date of last news or the point date (12 months).

Trial Locations

Locations (2)

Centre Oscar Lambret; 🇫🇷 Lille, France

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France