Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers

NCT04179773 | Terminated

• 2 other identifiers: RNI2018_412018-A01781-54
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Cirrhosis; Neoplasms

Keywords

Liver cirrhosis; chemotherapy; ENT cancers; upper-digestive tract cancers; colorectal cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• Survival time

  the date of death, the date of last news or the point date (12 months).

• 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).

• 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

Study Arms (2)

Cirrhotic patients

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

Other: Current care study

Non-cirrhotic patients

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

Other: Current care study

Interventions

Current care study OTHER

Observational study in two parts: 1. 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. 2. 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.

Cirrhotic patients; Non-cirrhotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients selected are patients with ENT, upper digestive-tract cancer and colorectal cancer from 2 hospitals: the University Hospital of Lille and the Oscar Lambret Centre. The study population consists of patients with a theoretical indication of conventional chemotherapy according to the usual guidelines for the management presented in multidisciplinary board. Prospective follow-up will be carried out on the population of patients receiving effective administration of a first course of chemotherapy. Patients in theoretical indications who are not receiving chemotherapy will be included in the first part of the study, but prospective follow-up will not be performed in this population. Exposed subjects who have received a first course of chemotherapy will be followed prospectively. Non-exposed subjects will be matched according to age (+/-5 years), ECOG/WHO classification, chemotherapy protocol and tumour location and followed prospectively.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Centre Oscar Lambret

Lille, France

Location

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Fibrosis; Neoplasms; Liver Cirrhosis; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Massih Ningarhari, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: January 24, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

FR (2)