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Trial record 1 of 1 for:    NCT00374036
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Metastatic Gastric Cancer FFCD 03-07

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ClinicalTrials.gov Identifier: NCT00374036
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : October 12, 2011
Sponsor:
Collaborators:
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Pfizer
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date October 12, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
  • Time of total survival and survival without progression [ Time Frame: 3 years ]
  • The percentage of objective answers in first and second line [ Time Frame: 1 year ]
  • Percentage of treated patients in second line [ Time Frame: 3 years ]
  • Control time of the disease [ Time Frame: 3 years ]
  • The tolerance, the quality of life, duration of hospitalization [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
  • Time of total survival and survival without progression
  • The percentage of objective answers in first and second line
  • Percentage of treated patients in second line
  • Control time of the disease
  • The tolerance, the quality of life, duration of hospitalization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metastatic Gastric Cancer FFCD 03-07
Official Title  ICMJE Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach
Brief Summary The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.
Detailed Description To compare the effectiveness of two different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stomach Cancer
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: ECC
    capecitabine
  • Drug: FOLFIRI
    Irinotecan
Study Arms  ICMJE
  • Experimental: 1
    ECC
    Intervention: Drug: ECC
  • Experimental: 2
    FOLFIRI
    Intervention: Drug: FOLFIRI
Publications * Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, André T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouché O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6. Erratum in: J Clin Oncol. 2015 Apr 20;33(12):1416.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 7, 2006)
416
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age = 18 years old
  • patients carrying a adenocarcinoma of the stomach or cardia histologically proven
  • locally advanced tumour which may not be treated surgically or metastatic tumour
  • the patients having a stenosante tumour responsible for a disphagy had to have a tumoral ablation or a prosthesis or a probe of food,
  • measurable lesions according to criteria RECIST (specify measurement by spiral scanner of largest diameter of with less the one lesion of size higher than 1 cm) or appraisable but nonmeasurable (lesions < 1 cm, ascite, pleural effusion...)
  • general state WHO < 2
  • absence of insufficiency cardiac or coronary symptomatic
  • absence of previous chemotherapy other that auxiliary stopped since more than 6 months
  • filled questionnaires QLQ C30 and STO-22
  • PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3
  • creatinin ≤ 110 micromol/l
  • bilirubin ≤ 35 micromol/l

Exclusion Criteria:

  • disphagy or intestinal obstruction incompatible with a treatment per os or by a probe of food
  • pregnant or nursing woman
  • previous of cardiac toxicity to the 5FU or to the anthracyclines
  • radiotherapy less than 3 weeks before inclusion, whatever the site
  • other evolutionary cancer threatening the short-term life
  • metastasis cerebral or méningée known (without obligation to seek it)
  • impossibility of regular follow-up for psychological, social, family or geographical reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374036
Other Study ID Numbers  ICMJE 0305603
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE
  • Federation Francophone de Cancerologie Digestive
  • Roche Pharma AG
  • Pfizer
Investigators  ICMJE
Principal Investigator: Rosine GUIMBAUD, MD CHU Toulouse
PRS Account University Hospital, Toulouse
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP