NCT01248299

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

November 24, 2010

Last Update Submit

May 14, 2019

Conditions

Squamous Cell Carcinoma of Esophagus

Keywords

ChemotherapyBest Supportive Care

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Between the date of randomisation and the date of death

Secondary Outcomes (4)

  • Progression free survival

    Between the date of randomisation and the date of progression

  • Tolerance

    At each visit : every 6 weeks

  • Quality of life by QLQ-C30

    Every 6 weeks

  • Cost analysis

    Every 6 weeks

Study Arms (2)

Chemotherapy plus best supportive care

EXPERIMENTAL

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

Drug: FU-CDDPDrug: LV5FU2-CDDPDrug: FOLFOXDrug: TPF

Best supportive care

ACTIVE COMPARATOR

Best supportive care with follow up every 6 weeks

Other: Best Supportive Care

Interventions

FU-CDDPDRUG

every 21 days: * Fluoro-uracil \[800 mg/m2, day 1 to day 5\] * CisPlatin \[75 mg/m2, day 1 or day 2\]

Also known as: Fluoro-uracil+CisPlatin
Chemotherapy plus best supportive care
LV5FU2-CDDPDRUG

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 \[50 mg/m2, day 2\]

Also known as: Elvorin+Fluoro-uracil+CisPlatin
Chemotherapy plus best supportive care
FOLFOXDRUG

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 \[500 mg/m2, day 1 and day 2\]

Also known as: Oxaliplatin+Fluoro-uracil+Elvorin
Chemotherapy plus best supportive care
TPFDRUG

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 \[700 mg/m2 /day, day 1 to day 5\]

Also known as: Docetaxel+CisPlatine+Fluoro-uracile
Chemotherapy plus best supportive care
Best Supportive CareOTHER

See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Also known as: antalgic treatment, nutritional support, ...
Best supportive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Non-progressive disease after the 6 first weeks of chemotherapy
  • Performance Status (ECOG) ≤ 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Brest

Brest, 29200, France

Location

Centre François BACLESSE

Caen, 14076, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

CHU Dijon

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CHU Lille

Lille, 59035, France

Location

CHU La Timone

Marseille, 13385, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Clinique de la Theuillerie

Ris-Orangis, 91130, France

Location

CHU Rouen

Rouen, 76031, France

Location

Clinique de l'Armoricaine

Saint-Brieuc, 22000, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Paul Strauss

Strasbourg, 67000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier Intercommunal

Villeneuve-Saint-Georges, 94190, France

Location

Related Publications (1)

  • 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.

    PMID: 26784946DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

5-FU-CDDP protocolFolfox protocolNutritional Support

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Antoine ADENIS, MD, PhD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)