Clinical trial · Interventional
Metastatic Gastric Cancer FFCD 03-07
Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach
NCT00374036CI-TRIAL-00005613completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ECC | Drug | — | UNRESOLVED |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- ECC
- interventionNames
- Drug: ECC
- type
- EXPERIMENTAL
- label
- 2
- description
- FOLFIRI
- interventionNames
- Drug: FOLFIRI
Primary outcomes (1)
- 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
- timeFrame
- 20 weeks
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGuimbaud 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 25287828