Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer (E-DIS2)

March 16, 2026 updated by: Centre Oscar Lambret

Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT

Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :

  • non randomized phase in which all patients will undergo chemotherapy
  • second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.

Randomized phase:

  • Arm A : pursuit of chemotherapy and best supportive care
  • Arm B : interruption of chemotherapy and best supportive care

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Arras, France, 62000
        • Hopital Privé Arras les Bonnettes
      • Boulogne-sur-Mer, France, 62200
        • Centre Hospitalier de Boulogne Sur Mer
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Nantes, France, 44805
        • Centre René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients suffering from squamous-cell type esophageal cancer histologically proved
  • Metastatic disease measurable according to RECIST criteria. Patients with metachronous metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible
  • Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt
  • Man or woman over 18 years old
  • ECOG performance status ≤ 2
  • Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥ 100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN
  • Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration
  • Affiliation to the National Social Security System
  • With informed and signed consent

Inclusion Criteria for randomization:

  • ECOG performance status ≤ 2
  • Able to pursuit the LV5FU2-paclitaxel chemotherapy
  • Non-progressive disease after the initial phase (first tumor exam at week 6)

Exclusion Criteria:

  • Patients who received more than one line of chemotherapy for a metastatic disease
  • Presence of other evolutive tumors
  • Cerebral metastasis or other known brain tumors
  • Severe liver failure
  • Pernicious anemia or other anemia due to vitamin B12 defficiency
  • Hypersensibility to an active substance or any other excipients of experimental drugs
  • Every unstable chronicle diseases that can affect patient confidence or security
  • Clinically significant active cardiac disease or myocardial infarction in the 6 previous months
  • Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin
  • Live attenuated vaccine within the 3 previous months
  • Pregnant or breastfeeding women
  • Unable to comply with the medical monitoring for geographic, social or mental issues
  • Patient Under guardianship or tutorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Pursuit of chemotherapy.
Drug: pursuit of chemotherapy
Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
Other Names:
  • LV5FU2-paclitaxel CT
No Intervention: Arm B
Interruption of chemotherapy, best supportive care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Estimate the overall survival for patients suffering from Esophageal cancer
Time Frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Non-progressive disease at and after 6 weeks of treatment until progression
From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimate efficiency in term of overall survival, of pursuing chemotherapy
Time Frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the efficiency in term of progression-free of pursuing chemotherapy
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment
From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the rate of non progressive patients
Time Frame: From date of inclusion until the date of the end the 6 firsts weeks of treatment
after the 6 firsts weeks of treatment
From date of inclusion until the date of the end the 6 firsts weeks of treatment
Estimate the overall survival of the whole study population
Time Frame: From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
beyond the inclusion
From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
Measure the toxicity of chemotherapy
Time Frame: from baseline up to 12 months
during the initial treatment phase compared to the 2 treatment arms after randomization
from baseline up to 12 months
Estimate the consequences of pursuing chemotherapy
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Oscar Lambret

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Farid EL HAJBI, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-DIS2-1006
  • 2017-003660-13 (EudraCT Number)
  • 170757A-12 (Other Identifier: ANSM)
  • API-16-32 (Other Grant/Funding Number: DGOS/INCA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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