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Completed

NCT Number: NCT00374036

Metastatic Gastric Cancer FFCD 03-07

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECC

Drug

capecitabine

FOLFIRI

Drug

Irinotecan

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

    Time frame: 20 weeks

Secondary outcomes

  1. Time of total survival and survival without progression

    Time frame: 3 years

  2. The percentage of objective answers in first and second line

    Time frame: 1 year

  3. Percentage of treated patients in second line

    Time frame: 3 years

  4. Control time of the disease

    Time frame: 3 years

  5. The tolerance, the quality of life, duration of hospitalization

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Federation Francophone de Cancerologie Digestive
  • Pfizer
  • Roche Pharma AG

Registry information

Official study title

Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 8, 2006
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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