NCT00374036

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

4.5 years

First QC Date

September 6, 2006

Last Update Submit

October 10, 2011

Conditions

Stomach CancerNeoplasm Metastasis

Keywords

chemotherapystomach cancer metastaticCapecitabineIrinotecan

Outcome Measures

Primary Outcomes (1)

  • Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line

    20 weeks

Secondary Outcomes (5)

  • Time of total survival and survival without progression

    3 years

  • The percentage of objective answers in first and second line

    1 year

  • Percentage of treated patients in second line

    3 years

  • Control time of the disease

    3 years

  • The tolerance, the quality of life, duration of hospitalization

    3 years

Study Arms (2)

1

EXPERIMENTAL

ECC

Drug: ECC

2

EXPERIMENTAL

FOLFIRI

Drug: FOLFIRI

Interventions

ECCDRUG

capecitabine

1
FOLFIRIDRUG

Irinotecan

2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

  • Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, Andre T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouche O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur 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.

    PMID: 25287828DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rosine GUIMBAUD, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

FR(1)