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Squamous Cell Carcinoma of EsophagusPhase 2E-DISNCT01248299

Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

A Phase 2 study testing FU-CDDP, LV5FU2-CDDP and FOLFOX in people with Squamous Cell Carcinoma of Esophagus, run by Centre Oscar Lambret at 17 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type The secondary aims would be to study : toxicity, the overall survival rate, a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Esophagus
What is being tested?
FU-CDDP, LV5FU2-CDDP and FOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
17 sitesFrance
Study dates
Jan 2011to Jan 2017
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 with an histologically proven epidermoid cancer of the oesophagus
  • Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields
  • Patients who may or may not have undergone radiochemotherapy
  • Patients who have not received chemotherapy for metastatic disease
  • ≥ 18 ans
  • Performance Status (ECOG) ≤ 2
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  • People who are covered by private or state health insurance
  • Informed consent signed by the patient
  • Non-progressive disease after the 6 first weeks of chemotherapy
  • Performance Status (ECOG) ≤ 2

Who cannot join

  • Other evolutive malignant tumor
  • Infection with HIV-1, HIV-2 or chronic hepatitis B or C
  • Cerebral metastasis or known meningeal tumor
  • Any unstable chronic diseases that could risk the safety or the compliance of te patient
  • Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab
  • Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons
  • For the randomized part

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CHU Brest

    Brest, 29200

  • Centre François BACLESSE

    Caen, 14076

  • Centre Georges François Leclerc

    Dijon, 21079

  • CHU Dijon

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • CHU Lille

    Lille, 59035

  • CHU La Timone

    Marseille, 13385

  • Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Eugène Marquis

    Rennes, 35042

  • Clinique de la Theuillerie

    Ris-Orangis, 91130

  • CHU Rouen

    Rouen, 76031

  • Clinique de l'Armoricaine

    Saint-Brieuc, 22000

  • Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre Paul Strauss

    Strasbourg, 67000

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges, 94190

Other trials in France

About this study

Official title: A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

Read the detailed description

As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.

Being tested
FU-CDDP, LV5FU2-CDDP, FOLFOX, TPF, Best Supportive Care
Keywords
Chemotherapy, Best Supportive Care
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.

  • FU-CDDPDrug

    Also called Fluoro-uracil+CisPlatin

    every 21 days:

    • Fluoro-uracil [800 mg/m2, day 1 to day 5]
    • CisPlatin [75 mg/m2, day 1 or day 2]

  • LV5FU2-CDDPDrug

    Also called Elvorin+Fluoro-uracil+CisPlatin

    every 14 days:

    • Elvorin [200 mg/m2, 2h IV, day 1 and day 2]
    • Fluoro-uracil [400 mg/m2 as a bolus, day 1 and day 2]
    • Fluoro-uracil [600 mg/m2, 22h continous infusion, day 1 and day 2]
    • CisPlatin [50 mg/m2, day 2]

  • FOLFOXDrug

    Also called Oxaliplatin+Fluoro-uracil+Elvorin

    every 14 days:

    • Oxaliplatin [85 mg/m2 by 2h infusion, day 1]
    • Fluoro-uracil [400 mg/m2 as a bolus, day 1 and day 2]
    • Fluoro-uracil [600 mg/m2, by 22h continous infusion, day 1 and day 2]
    • Elvorin [500 mg/m2, day 1 and day 2]

  • TPFDrug

    Also called Docetaxel+CisPlatine+Fluoro-uracile

    every 21 days:

    • Docetaxel [30 mg/m2, day 1 and day 8]
    • CisPlatin [60 mg/m2, day 1]
    • Fluoro-uracil [200 mg/m2/day by continous infusion]

    Or every 21 days:

    • Docetaxel [50 mg/m2, day 1]
    • CisPlatine [70 mg/m2, day 1]
    • Fluoro-uracile [700 mg/m2 /day, day 1 to day 5]

  • Best Supportive CareOther

    Also called antalgic treatment, nutritional support, ...

    See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Study groups in NCT01248299
Study groupRoleWhat they receive
Chemotherapy plus best supportive careExperimentalChemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Receives: Drug: FU-CDDP; Drug: LV5FU2-CDDP; Drug: FOLFOX; Drug: TPF
Best supportive careActive comparatorBest supportive care with follow up every 6 weeks
Receives: Other: Best Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Between the date of randomisation and the date of death

Secondary outcomes (4)

  1. Progression free survival

    Measured: Between the date of randomisation and the date of progression

  2. Tolerance

    According to the NCI-CTCAE V4.0 grading scale

    Measured: At each visit : every 6 weeks

  3. Quality of life by QLQ-C30

    EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module

    EQ-5D questionnaire

    Measured: Every 6 weeks

  4. Cost analysis

    Data collected :

    • Hospitalization
    • day hospital visit
    • Chemotherapy drugs administered
    • Home medical care
    • Radiotherapy
    • Oncologist visits, General Practitioner Visits
    • Laboratory and radiologic tests

    Measured: Every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2016
  4. Study completionJan 2017

Resources

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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01248299
Sponsor's protocol ID
E-DIS 2010-06
Other IDs
2010-021439-16
Acronym
E-DIS
Status last verified
May 2019
First submitted
24 Nov 2010
Last updated
16 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kotecki N, Hiret S, Etienne PL, Penel N, Tresch E, Francois E, Galais MP, Ben Abdelghani M, Michel P, Dahan L, Ghiringelli F, Bedenne L, Samalin E, Piessen G, Bennouna J, Peugniez C, El Hajbi F, Clisant S, Kramar A, Mariette C, Adenis A. First-Line Chemotherapy for Metastatic Esophageal Squamous Cell Carcinoma: Clinico-Biological Predictors of Disease Control. Oncology. 2016;90(2):88-96. doi: 10.1159/000442947. Epub 2016 Jan 20.

    PubMed 26784946

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FU-CDDP, LV5FU2-CDDP and FOLFOX in people with Squamous Cell Carcinoma of Esophagus, run by Centre Oscar Lambret at 17 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 10 inclusion and 7 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. 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?

Overall survival (time frame: Between the date of randomisation and the date of death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01248299, which also lists 1 linked publication.

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 16 May 2019.

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