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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01248299
First received: November 24, 2010
Last updated: May 23, 2016
Last verified: May 2016
  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:


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


Enrollment: 105
Study Start Date: January 2011
Estimated Study Completion Date: September 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 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, ...

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248299

Locations
France
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 René Gauducheau
Nantes Saint-herblain, France, 44805
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
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
Investigators
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01248299     History of Changes
Other Study ID Numbers: E-DIS 2010-06  2010-021439-16 
Study First Received: November 24, 2010
Last Updated: May 23, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
Chemotherapy
Best Supportive Care

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
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
Docetaxel
Oxaliplatin
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016