Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers

Neoplasms Clinical Trial

— CHIMIOSE  

Official title:

Prospective Observational Study Studying the Influence of the Presence of Liver Cirrhosis During Chemotherapy for ENT Cancer, Upper Digestive Tract Cancer or Colorectal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179773
• Other study ID #: RNI2018_41
• Secondary ID: 2018-A01781-54
• Status: Recruiting
• Start date: January 24, 2019
• Est. completion date: January 2025

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: Massih Ningarhari, MD
• Phone: 03.20.44.43.37
• Email: massih.ningarhari[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Neoplasms

Intervention

Other:
• Current care study
Observational study in two parts: Cross-sectional study of patients with digestive or ENT cancer with indication for conventional chemotherapy treatment according to management guidelines, the objective of which is to determine the frequency of cirrhosis. Exposed/non-exposed cohort study of patients receiving a first course of conventional chemotherapy initiated in outpatient oncology clinic. (safety population). Exposed subjects will be patients with cirrhosis, included consecutively. Non-exposed subjects will be non-cirrhotic patients. They will be selected non-consecutively according to the following criteria, for matching to exposed subjects: age (±5 years), type of cancer (digestive vs. ENT), treatment stage (curative vs. palliative). Two unexposed subjects will be selected for 1 exposed subject.

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Survival time	Survival time defined as the difference between the date of initiation of chemotherapy,	the date of death, the date of last news or the point date (12 months).
Secondary	Progression-free survival time	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).	the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months).
Secondary	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