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

May 14, 2019 updated by: Centre Oscar Lambret

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • 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 Locations

  • France
      • Brest, France, 29200
        • Chu Brest
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Dijon, France, 21079
        • CHU Dijon
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59035
        • Chu Lille
      • Marseille, France, 13385
        • CHU La Timone
      • Montpellier, France, 34298
        • Centre Val d'Aurelle
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Ris Orangis, France, 91130
        • Clinique de la Theuillerie
      • Rouen, France, 76031
        • Chu Rouen
      • Saint-Herblain, France, 44805
        • Centre René Gauducheau
      • St-Brieuc, France, 22000
        • Clinique de l'Armoricaine
      • Strasbourg, France, 67000
        • Centre Paul Strauss
      • Vandoeuvre-les-nancy, France, 54511
        • Centre Alexis Vautrin
      • Villeneuve St Georges, France, 94190
        • Centre Hospitalier Intercommunal

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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, ...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Between the date of randomisation and the date of death
Between the date of randomisation and the date of death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Between the date of randomisation and the date of progression
Between the date of randomisation and the date of progression
Tolerance
Time Frame: At each visit : every 6 weeks
According to the NCI-CTCAE V4.0 grading scale
At each visit : every 6 weeks
Quality of life by QLQ-C30
Time Frame: Every 6 weeks

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

EQ-5D questionnaire
Every 6 weeks
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
Every 6 weeks

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Collaborators

National Cancer Institute, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2011

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (ESTIMATE)

November 25, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-DIS 2010-06
  • 2010-021439-16 (OTHER: IDRCB Number - AFSSAPS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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