Clinical trial NCT04179773: Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers
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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cirrhosis
Neoplasms
Keywords: Liver cirrhosis
chemotherapy
ENT cancers
upper-digestive tract cancers
colorectal cancers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis
timeFrame: before the chemotherapy initiation, within 45 days of multidisciplinary board
Secondary outcomes:
measure: Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy
timeFrame: within 45 days of multidisciplinary board.
measure: Survival time
timeFrame: the date of death, the date of last news or the point date (12 months).
measure: Progression-free survival time
timeFrame: the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months).
measure: Frequency of chemotherapy side effects according to CTCAE version 5.0 classification in cirrhotic patients who have received chemotherapy
timeFrame: Up to 5 years after chemotherapy
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Massih Ningarhari, MD
role: PRINCIPAL_INVESTIGATOR
References: