Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
NCT ID: NCT01248299
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
105 participants
INTERVENTIONAL
2011-01-31
2017-01-31
Brief Summary
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The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
FU-CDDP
every 21 days:
* Fluoro-uracil \[800 mg/m2, day 1 to day 5\]
* CisPlatin \[75 mg/m2, day 1 or day 2\]
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 \[50 mg/m2, day 2\]
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 \[500 mg/m2, day 1 and day 2\]
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 \[700 mg/m2 /day, day 1 to day 5\]
Best supportive care
Best supportive care with follow up every 6 weeks
Best Supportive Care
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...
Interventions
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FU-CDDP
every 21 days:
* Fluoro-uracil \[800 mg/m2, day 1 to day 5\]
* CisPlatin \[75 mg/m2, day 1 or day 2\]
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 \[50 mg/m2, day 2\]
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 \[500 mg/m2, day 1 and day 2\]
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 \[700 mg/m2 /day, day 1 to day 5\]
Best Supportive Care
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Non-progressive disease after the 6 first weeks of chemotherapy
* Performance Status (ECOG) ≤ 2
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Antoine ADENIS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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CHU Brest
Brest, , France
Centre François BACLESSE
Caen, , France
Centre Georges François Leclerc
Dijon, , France
CHU Dijon
Dijon, , France
Centre Oscar Lambret
Lille, , France
CHU Lille
Lille, , France
CHU La Timone
Marseille, , France
Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Centre Eugène Marquis
Rennes, , France
Clinique de la Theuillerie
Ris-Orangis, , France
CHU Rouen
Rouen, , France
Clinique de l'Armoricaine
Saint-Brieuc, , France
Centre René Gauducheau
Saint-Herblain, , France
Centre Paul Strauss
Strasbourg, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, , France
Countries
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References
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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.
Other Identifiers
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2010-021439-16
Identifier Type: OTHER
Identifier Source: secondary_id
E-DIS 2010-06
Identifier Type: -
Identifier Source: org_study_id
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