Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers (CHIMIOSE)

University Hospital, Lille

Status: Terminated

Conditions: Neoplasms; Cirrhosis

Treatments: Other: Current care study

Study type: Observational

Funder types: Other

Identifiers

NCT04179773

RNI2018_41

2018-A01781-54 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 2 patient groups

Cirrhotic patients

Description:

Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging)

Treatment:

Other: Current care study

Non-cirrhotic patients

Description:

Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging)

Treatment:

Other: Current care study