- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00811447
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Primary objective:
To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])
Secondary objectives:
- To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
- To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
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Shanghai, Chine
- Sanofi-Aventis Administrative Office
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion.
- Performance status Karnofsky index >70%
- Life expectancy of more than 3 months
- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
- Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value
- Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL
- No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant therapy and first relapse.
- At least 6 weeks from prior radiotherapy and 3 weeks from surgery
- Complete initial work-up within two weeks prior to first infusion for clinical evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.
Exclusion Criteria:
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
- Other tumor type than adenocarcinoma
- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant
- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose > 300mg/m²
- Previous or current malignancies other than gastric carcinoma, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
- Patients with known brain or leptomeningeal metastases
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria
Other serious illness or medical conditions:
- unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or seizures
- active uncontrolled infection
- active disseminated intravascular coagulation
- other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment at low doses
- Definite contraindications for the use of corticosteroids
- Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml
- Liver impairment with AST or ALT more than 1.5UNL associated with alkaline phosphatase more than 2.5UNL
- Concurrent or within 4 week period administration of any other experimental drugs
- Concurrent treatment with any other anti-cancer therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
|
600 mg/m²/day intravenous
60 mg/m² or 75 mg/m² intravenous
60 mg/m² intravenous
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Comparateur actif: 2
Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5.
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600 mg/m²/day intravenous
60 mg/m² or 75 mg/m² intravenous
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Time to progression
Délai: Throughout the study period
|
Throughout the study period
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Safety profile
Délai: Throughout the study period
|
Throughout the study period
|
Overall survival
Délai: From beginning to end of study
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From beginning to end of study
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Tumor response
Délai: every 8 weeks
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every 8 weeks
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Clinical toxicities/symptomatology
Délai: Throughout the study period
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Throughout the study period
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Laboratory toxicities/symptomatology
Délai: Throughout the study period
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Throughout the study period
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Martin Thoenes, Sanofi
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de l'estomac
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Docétaxel
- Cisplatine
- Fluorouracile
Autres numéros d'identification d'étude
- DOCET_L_02195
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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