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Trial record 50 of 283 for:    Best Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248299
Recruitment Status : Terminated
First Posted : November 25, 2010
Last Update Posted : May 16, 2019
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief 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 study of costs and quality of life.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Esophagus Drug: FU-CDDP Drug: LV5FU2-CDDP Drug: FOLFOX Drug: TPF Other: Best Supportive Care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 .
Actual Study Start Date : January 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Chemotherapy plus best supportive care
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF

every 21 days:

  • Fluoro-uracil [800 mg/m2, day 1 to day 5]
  • CisPlatin [75 mg/m2, day 1 or day 2]
Other Name: 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]
Other Name: Elvorin+Fluoro-uracil+CisPlatin


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]
Other Name: Oxaliplatin+Fluoro-uracil+Elvorin

Drug: TPF

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]
Other Name: Docetaxel+CisPlatine+Fluoro-uracile

Active Comparator: Best supportive care
Best supportive care with follow up every 6 weeks
Other: Best Supportive Care
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...
Other Name: antalgic treatment, nutritional support, ...

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Between the date of randomisation and the date of death ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Between the date of randomisation and the date of progression ]
  2. Tolerance [ Time Frame: At each visit : every 6 weeks ]
    According to the NCI-CTCAE V4.0 grading scale

  3. Quality of life by QLQ-C30 [ Time Frame: Every 6 weeks ]

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

    EQ-5D questionnaire

  4. Cost analysis [ Time Frame: Every 6 weeks ]

    Data collected :

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • People who are covered by private or state health insurance
  • Informed consent signed by the patient

Exclusion Criteria:

  • 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

Inclusion criteria :

  • Non-progressive disease after the 6 first weeks of chemotherapy
  • Performance Status (ECOG) ≤ 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248299

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CHU Brest
Brest, France, 29200
Centre François BACLESSE
Caen, France, 14076
Centre Georges François Leclerc
Dijon, France, 21079
CHU Dijon
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
CHU Lille
Lille, France, 59035
CHU La Timone
Marseille, France, 13385
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Centre Eugène Marquis
Rennes, France, 35042
Clinique de la Theuillerie
Ris Orangis, France, 91130
CHU Rouen
Rouen, France, 76031
Centre René Gauducheau
Saint-Herblain, France, 44805
Clinique de l'Armoricaine
St-Brieuc, France, 22000
Centre Paul Strauss
Strasbourg, France, 67000
Centre Alexis Vautrin
Vandoeuvre-les-nancy, France, 54511
Centre Hospitalier Intercommunal
Villeneuve St Georges, France, 94190
Sponsors and Collaborators
Centre Oscar Lambret
National Cancer Institute, France
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Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret Identifier: NCT01248299     History of Changes
Other Study ID Numbers: E-DIS 2010-06
2010-021439-16 ( Other Identifier: IDRCB Number - AFSSAPS )
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
Best Supportive Care

Additional relevant MeSH terms:
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Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs