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

Sponsor
Centre Oscar Lambret (Other)
Overall Status
Terminated
CT.gov ID
NCT01248299
Collaborator
National Cancer Institute, France (Other)
105
Enrollment
17
Locations
2
Arms
72
Actual Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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

Drug: FU-CDDP
every 21 days: Fluoro-uracil [800 mg/m2, day 1 to day 5] CisPlatin [75 mg/m2, day 1 or day 2]
Other Names:
  • Fluoro-uracil+CisPlatin

    • Drug: LV5FU2-CDDP
    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 Names:
  • Elvorin+Fluoro-uracil+CisPlatin

    • Drug: FOLFOX
    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 Names:
  • 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 Names:
  • 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 Names:
  • antalgic treatment, nutritional support, ...

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [Between the date of randomisation and the date of death]

    Secondary Outcome Measures

    1. Progression free survival [Between the date of randomisation and the date of progression]

    2. Tolerance [At each visit : every 6 weeks]

      According to the NCI-CTCAE V4.0 grading scale

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

      EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire

    4. Cost analysis [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Brest Brest France 29200
    2 Centre François BACLESSE Caen France 14076
    3 Centre Georges François Leclerc Dijon France 21079
    4 CHU Dijon Dijon France 21079
    5 Centre Oscar Lambret Lille France 59020
    6 CHU Lille Lille France 59035
    7 CHU La Timone Marseille France 13385
    8 Centre Val d'Aurelle Montpellier France 34298
    9 Centre Antoine Lacassagne Nice France 06189
    10 Centre Eugène Marquis Rennes France 35042
    11 Clinique de la Theuillerie Ris Orangis France 91130
    12 CHU Rouen Rouen France 76031
    13 Centre René Gauducheau Saint-Herblain France 44805
    14 Clinique de l'Armoricaine St-Brieuc France 22000
    15 Centre Paul Strauss Strasbourg France 67000
    16 Centre Alexis Vautrin Vandoeuvre-les-nancy France 54511
    17 Centre Hospitalier Intercommunal Villeneuve St Georges France 94190

    Sponsors and Collaborators

    • Centre Oscar Lambret
    • National Cancer Institute, France

    Investigators

    • Principal Investigator: Antoine ADENIS, MD, PhD, Centre Oscar Lambret

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Oscar Lambret
    ClinicalTrials.gov Identifier:
    NCT01248299
    Other Study ID Numbers:
    • E-DIS 2010-06
    • 2010-021439-16
    First Posted:
    Nov 25, 2010
    Last Update Posted:
    May 16, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Centre Oscar Lambret
    Chemotherapy
    Best Supportive Care
    Additional relevant MeSH terms:
    Esophageal Neoplasms
    Esophageal Squamous Cell Carcinoma
    Cisplatin
    Docetaxel
    Oxaliplatin
    Fluorouracil

    Study Results

    No Results Posted as of May 16, 2019