Esophageal Cancer, Squamous CellPhase 2E-DIS2NCT03301454
Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
A Phase 2 study testing pursuit of chemotherapy in people with Esophageal Cancer, Squamous Cell, run by Centre Oscar Lambret at 5 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Squamous Cell
- What is being tested?
- pursuit of chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesFrance
- Study dates
- 20 Aug 2018to 5 Jul 2022
- Phase
- Phase 2
- 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
Who may be able to join
- 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
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- 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
- ECOG performance status ≤ 2
- Able to pursuit the LV5FU2-paclitaxel chemotherapy
- Non-progressive disease after the initial phase (first tumor exam at week 6)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Privé Arras Les Bonnettes
Arras, 62000
Centre Hospitalier de Boulogne sur mer
Boulogne-sur-Mer, 62200
Centre François Baclesse
Caen, 14076
Centre Oscar Lambret
Lille, 59020
Centre René Gauducheau
Nantes, 44805
About this study
Official title: 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
Read the 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
- Conditions
- Esophageal Cancer, Squamous Cell
- Being tested
- pursuit of chemotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pursuit of chemotherapyDrug
Also called LV5FU2-paclitaxel CT
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Pursuit of chemotherapy. Receives: Drug: pursuit of chemotherapy |
| Arm B | No intervention | Interruption of chemotherapy, best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the overall survival for patients suffering from Esophageal cancer
Non-progressive disease at and after 6 weeks of treatment until progression
Measured: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Secondary outcomes (6)
Estimate efficiency in term of overall survival, of pursuing chemotherapy
beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
Measured: 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
beyond 6 weeks of treatment
Measured: 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
after the 6 firsts weeks of treatment
Measured: 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
beyond the inclusion
Measured: 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
during the initial treatment phase compared to the 2 treatment arms after randomization
Measured: from baseline up to 12 months
Estimate the consequences of pursuing chemotherapy
beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start20 Aug 2018
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Why it stopped: This decision was taken on June 20 2022 due to low recruitment over the past 4 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer, Squamous CellStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid EL HAJBI, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301454
- Sponsor's protocol ID
- E-DIS2-1006
- Other IDs
- API-16-32, 2017-003660-13, 170757A-12, 2017
- Acronym
- E-DIS2
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2017
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03301454
- Acronym / sponsor ID
- E-DIS2 / E-DIS2-1006
- Conditions
- Esophageal Cancer, Squamous Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision was taken on June 20 2022 due to low recruitment over the past 4 years.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 4 Oct 2017 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: pursuit of chemotherapyPursuit of chemotherapy. |
| Arm B | No intervention | –Interruption of chemotherapy, best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| pursuit of chemotherapyAlso: LV5FU2-paclitaxel CTTreatment 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 | Drug | Arm A |
Primary outcome
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
6 secondary outcomes
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
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
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
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
Measure the toxicity of chemotherapy
Time frame: 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
Results and safety
The study was stopped early (reason given: This decision was taken on June 20 2022 due to low recruitment over the past 4 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Farid EL HAJBI, MD principal investigator
Centre Oscar Lambret
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pursuit of chemotherapy in people with Esophageal Cancer, Squamous Cell, run by Centre Oscar Lambret at 5 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 12 inclusion and 14 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This decision was taken on June 20 2022 due to low recruitment over the past 4 years.). 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?
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). 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 18 Mar 2026.