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

This study is currently recruiting participants.
Verified May 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01248299
First received: November 24, 2010
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 .

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Between the date of randomisation and the date of death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Between the date of randomisation and the date of progression ] [ Designated as safety issue: No ]
  • Tolerance [ Time Frame: At each visit : every 6 weeks ] [ Designated as safety issue: Yes ]
    According to the NCI-CTCAE V4.0 grading scale

  • Quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

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

    EQ-5D questionnaire


  • Cost analysis [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

    Data collected :

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


Estimated Enrollment: 88
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy plus best supportive care 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]
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]
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]
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]
Experimental: Best supportive care Other: Best Supportive Care
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248299

Contacts
Contact: Antoine ADENIS, MD +33(0)320295290 a-adenis@o-lambret.fr
Contact: Yvette VENDEL, Sponsor CRA +33(0)320295940 y-vendel@o-lambret.fr

Locations
France
CHU Brest Recruiting
Brest, France, 29200
Contact: Jean-Philippe METGES, MD     +33(0)298223333     jean-philippe.metges@chu-brest.fr    
Sub-Investigator: Véronique LE TALLEC JESTIN, MD            
Sub-Investigator: Cédric VERVEUR, MD            
Principal Investigator: Jean-Philippe METGES, MD            
Centre François BACLESSE Recruiting
Caen, France, 14076
Contact: Marie-Pierre GALAIS, MD     +33(0)2 31 45 50 16     mp.galais@baclesse.fr    
Sub-Investigator: Anne-Charlotte LEFEBVRE, MD            
Sub-Investigator: Jean-Marc GUILLOIT, MD            
Sub-Investigator: Che Mabubu M'VONDO, MD            
Sub-Investigator: Carmen FLORESCU, MD            
Sub-Investigator: Jacques-Henri JACOB, MD            
Sub-Investigator: Jean-Michel OLLIVIER, MD            
Principal Investigator: Marie-Pierre GALAIS, MD            
Sub-Investigator: Françoise POLYCARPE-OSAER, MD            
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: Francois GHIRINGHELLI, MD         fghiringhelli@dijon.fnclcc.fr    
Sub-Investigator: Véronique LORGIS, MD            
Principal Investigator: François GHIRINGHELLI, MD            
CHU Dijon Recruiting
Dijon, France, 21079
Contact: Laurent BEDENNE, MD, PhD     03 80 29 37 50     laurent.bedenne@chu-dijon.fr    
Principal Investigator: Laurent BEDENNE, MD, PhD            
Sub-Investigator: Jean-Louis JOUVE, MD            
Sub-Investigator: Alice GAGANAIRE, MD            
Sub-Investigator: Côme LEPAGE, MD            
Sub-Investigator: Mathilde DAVID, MD            
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Antoine ADENIS, MD     +33(0)320295920     a-adenis@o-lambret.fr    
Sub-Investigator: Sophie DOMINGUEZ, MD            
Sub-Investigator: Eric AMELA, MD            
Principal Investigator: Antoine ADENIS, MD, PhD            
CHU Lille Recruiting
Lille, France, 59035
Contact: Mohammed HEBBAR, MD     +33(0)320445461     m-hebbar@chru-lille.fr    
Sub-Investigator: Olivier ROMANO, MD            
Sub-Investigator: Vincent BOURGEOIS, MD            
Principal Investigator: Mohamed HEBBAR, MD            
CHU La Timone Recruiting
Marseille, France, 13385
Contact: Jean-François SEITZ, MD         jean-francois.seitz@ap-hm.fr    
Sub-Investigator: Laetitia DAHAN, MD            
Sub-Investigator: Pauline RIES-GUYE, MD            
Sub-Investigator: Muriel DULUC, MD            
Sub-Investigator: Emmanuelle NORGUET-MONNEREAU, MD            
Principal Investigator: Jean-François SEITZ, MD, PhD            
Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Emmanuelle SAMALIN, MD     +33(0)467612592     emmanuelle.samalin@valdorel.fnclcc.fr    
Sub-Investigator: Marc YCHOU, MD            
Sub-Investigator: Eric ASSENAT, MD            
Sub-Investigator: Fabienne PORTALES, MD            
Principal Investigator: Emmanuelle SAMALIN, MD            
Centre René Gauducheau Recruiting
Nantes Saint-herblain, France, 44805
Contact: Jaafar BENNOUNA         j-bennouna@nantes.fnclcc.fr    
Sub-Investigator: Jean-Yves DOUILLARD, MD            
Sub-Investigator: Hélène SENELLART, MD            
Sub-Investigator: Sandrine HIRET, MD            
Principal Investigator: Jaafar BENNOUNA, MD            
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Eric FRANCOIS, MD     +33(0)4 92 03 16 13     eric.francois@nice.fnclcc.fr    
Sub-Investigator: Philippe FOLLANA, MD            
Principal Investigator: Eric FRANCOIS, MD            
Sub-Investigator: Véronique MARI, MD            
Sub-Investigator: Gérard CAVAGLIONE, MD            
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Eveline BOUCHER, MD     +33(0)2 99 25 31 96     boucher@rennes.fnclcc.fr    
Sub-Investigator: Sylvain MANFREDI, MD            
Sub-Investigator: Bérengère LECONTE, MD            
Principal Investigator: Eveline BOUCHER, MD            
CHU Rouen Recruiting
Rouen, France, 76031
Contact: Pierre MICHEL, MD, PhD     +33(0)232886450 poste 66456     pierre.michel@chu-rouen.fr    
Sub-Investigator: Frédéric DI FIORE, MD            
Sub-Investigator: Isabelle IWANICKI-CARO, MD            
Sub-Investigator: Valérie BLONDIN, MD            
Sub-Investigator: Alice ODEN-GANGLOFF, MD            
Sub-Investigator: Aude DI FIORE, MD            
Principal Investigator: Pierre MICHEL, MD, PhD            
Clinique de l'Armoricaine Recruiting
St-Brieuc, France, 22000
Contact: Pierre-Luc ETIENNE     +33(0)296752216     aude.vincent@clin-armoricaine.fr    
Sub-Investigator: Dominique BESSON, MD            
Sub-Investigator: Anne-Claire HARDY-BESSARD, MD            
Principal Investigator: Pierre-Luc ETIENNE, MD            
Centre Paul Strauss Recruiting
Strasbourg, France, 67000
Contact: Meher BEN ABDELGHANI, MD     03 88 25 24 85     mbenabdelghani@strasbourg.unicancer.fr    
Principal Investigator: Meher BEN ABDELGHANI, MD            
Sub-Investigator: Christine BELLETIER, MD            
Sub-Investigator: Christian BOREL, MD            
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-nancy, France, 54511
Contact: Thierry CONROY, MD, PhD     +33(0)383598460     t.conroy@nancy.fnclcc.fr    
Sub-Investigator: Marie-Christine KAMINSKY, MD            
Principal Investigator: Thierry CONROY, MD, PhD            
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01248299     History of Changes
Other Study ID Numbers: E-DIS 2010-06
Study First Received: November 24, 2010
Last Updated: May 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
Chemotherapy
Best Supportive Care

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013