CirrhosisCHIMIOSENCT04179773
Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers
An observational study of Cirrhosis and Neoplasms, run by University Hospital, Lille at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Current care study
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jan 2019to 25 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Other concomitant primary cancer
- Pregnant women
- Patients under guardianship, curatorship or justice protection
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read more
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.
- Being tested
- Current care study
- Keywords
- Liver cirrhosis, chemotherapy, ENT cancers, upper-digestive tract cancers, colorectal cancers
- Medical subject headings
- Fibrosis, Neoplasms, Liver Cirrhosis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current care studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients | Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging) Receives: 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) Receives: Other: Current care study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis
Measured: 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
Measured: within 45 days of multidisciplinary board.
Survival time
Survival time defined as the difference between the date of initiation of chemotherapy,
Measured: the date of death, the date of last news or the point date (12 months).
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).
Measured: 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
Measured: Up to 5 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start24 Jan 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massih Ningarhari, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179773
- Sponsor's protocol ID
- RNI2018_41
- Other IDs
- 2018-A01781-54
- Acronym
- CHIMIOSE
- Status last verified
- Jan 2025
- First submitted
- 25 Nov 2019
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04179773
- Acronym / sponsor ID
- CHIMIOSE / RNI2018_41
- Keywords
- Liver cirrhosis, chemotherapy, ENT cancers, upper-digestive tract cancers, colorectal cancers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients | – | Other: Current care studyCurrent care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging) |
| Non-cirrhotic patients | – | Other: Current care studyCurrent care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other concomitant primary cancer
- Pregnant women
- Patients under guardianship, curatorship or justice protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current care studyObservational 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. | Other | Cirrhotic patients, Non-cirrhotic patients |
Primary outcome
Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis
Time frame: before the chemotherapy initiation, within 45 days of multidisciplinary board
4 secondary outcomes
Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy
Time frame: within 45 days of multidisciplinary board.
Survival time
Time frame: the date of death, the date of last news or the point date (12 months).
Progression-free survival time
Time frame: 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
Time frame: Up to 5 years after chemotherapy
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massih Ningarhari, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Neoplasms, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis (time frame: before the chemotherapy initiation, within 45 days of multidisciplinary board). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.