- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00201344
A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.
Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.
Type d'étude
Inscription
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 112
- Veterans General Hospital-Taipei
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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:
- Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
- Original stage must be stage IV disease (M0)
- Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
- Performance status scale ECOG grade 0,1.
- Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl.
- Patients must be younger than 70 year-old.
- Patients must give signed informed consent.
Exclusion Criteria:
- Patients had progressive disease after radiotherapy
- Patients had evidence of distant metastasis.
- Patients had completed radiotherapy for more than 7 weeks.
- The presence of life-threatening illness
- History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
- Previous chemotherapy.
- Pregnancy.
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)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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overall survival, relapse free survival,distant metastasis and local-regional control rates.
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Mesures de résultats secondaires
Mesure des résultats |
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toxicities of the two treatment methods.
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Kwan-Hwa Chi, MD,, Taiwan cooperative oncology group
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
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
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Tumeurs, glandulaires et épithéliales
- Tumeurs pharyngées
- Tumeurs oto-rhino-laryngologiques
- Tumeurs de la tête et du cou
- Maladies nasopharyngées
- Maladies pharyngées
- Maladies stomatognathiques
- Maladies oto-rhino-laryngologiques
- Tumeurs du nasopharynx
- Carcinome
- Carcinome du nasopharynx
- Effets physiologiques des médicaments
- Agents protecteurs
- Micronutriments
- Vitamines
- Antidotes
- Complexe de vitamine B
- Leucovorine
Autres numéros d'identification d'étude
- T1394
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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