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

Primary Purpose

Squamous Cell Carcinoma of Esophagus

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FU-CDDP
LV5FU2-CDDP
FOLFOX
TPF
Best Supportive Care
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Esophagus focused on measuring Chemotherapy, Best Supportive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Brest
  • Centre François BACLESSE
  • Centre Georges François Leclerc
  • CHU Dijon
  • Centre Oscar Lambret
  • CHU Lille
  • CHU La Timone
  • Centre Val d'Aurelle
  • Centre Antoine Lacassagne
  • Centre Eugène Marquis
  • Clinique de la Theuillerie
  • CHU Rouen
  • Centre René Gauducheau
  • Clinique de l'Armoricaine
  • Centre Paul Strauss
  • Centre Alexis Vautrin
  • Centre Hospitalier Intercommunal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy plus best supportive care

Best supportive care

Arm Description

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

Best supportive care with follow up every 6 weeks

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression free survival
Tolerance
According to the NCI-CTCAE V4.0 grading scale
Quality of life by QLQ-C30
EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire
Cost analysis
Data collected : Hospitalization day hospital visit Chemotherapy drugs administered Home medical care Radiotherapy Oncologist visits, General Practitioner Visits Laboratory and radiologic tests

Full Information

First Posted
November 24, 2010
Last Updated
May 14, 2019
Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT01248299
Brief Title
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
Acronym
E-DIS
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 .
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2011 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Esophagus
Keywords
Chemotherapy, Best Supportive Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy plus best supportive care
Arm Type
Experimental
Arm Description
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Arm Title
Best supportive care
Arm Type
Active Comparator
Arm Description
Best supportive care with follow up every 6 weeks
Intervention Type
Drug
Intervention Name(s)
FU-CDDP
Other Intervention Name(s)
Fluoro-uracil+CisPlatin
Intervention Description
every 21 days: Fluoro-uracil [800 mg/m2, day 1 to day 5] CisPlatin [75 mg/m2, day 1 or day 2]
Intervention Type
Drug
Intervention Name(s)
LV5FU2-CDDP
Other Intervention Name(s)
Elvorin+Fluoro-uracil+CisPlatin
Intervention Description
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]
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
Oxaliplatin+Fluoro-uracil+Elvorin
Intervention Description
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]
Intervention Type
Drug
Intervention Name(s)
TPF
Other Intervention Name(s)
Docetaxel+CisPlatine+Fluoro-uracile
Intervention Description
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]
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Other Intervention Name(s)
antalgic treatment, nutritional support, ...
Intervention Description
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Between the date of randomisation and the date of death
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
Between the date of randomisation and the date of progression
Title
Tolerance
Description
According to the NCI-CTCAE V4.0 grading scale
Time Frame
At each visit : every 6 weeks
Title
Quality of life by QLQ-C30
Description
EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire
Time Frame
Every 6 weeks
Title
Cost analysis
Description
Data collected : Hospitalization day hospital visit Chemotherapy drugs administered Home medical care Radiotherapy Oncologist visits, General Practitioner Visits Laboratory and radiologic tests
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine ADENIS, MD, PhD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre François BACLESSE
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59035
Country
France
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Clinique de la Theuillerie
City
Ris Orangis
ZIP/Postal Code
91130
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique de l'Armoricaine
City
St-Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Villeneuve St Georges
ZIP/Postal Code
94190
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26784946
Citation
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.
Results Reference
derived

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

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