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

Phase 3
18 Years
Not Enrolling
Stomach Cancer, Neoplasm Metastasis

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

20 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2005

Completion Date:

December 2009

Related Keywords:

  • Stomach Cancer
  • Neoplasm Metastasis
  • chemotherapy
  • stomach cancer metastatic
  • Capecitabine
  • Irinotecan
  • stomach cancer metastatic
  • Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis