- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02058433
Safety Study of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetics in Non-Small Cell Lung Cancer (NSCLC)
Phase 3, Randomized, Open-label Study of the Safety of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetic Follow up Versus Conventional Dosage in First-line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Primary end point: Common Terminology Criteria for Adverse Events(CTCAE) grade 4.
Secondary end point:Objective Response Rate(ORR),Progression Free Survival(PFS),Overall Survival(OS),Quality Of Life(QOL) etc.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Shanghai
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Shanghai, Shanghai, Chine, 200433
- Recrutement
- Medical Department, Shanghai Pulmonary Hospital
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Sous-enquêteur:
- Jie Zhang, MD
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Sous-enquêteur:
- Huiwei Qi, MD
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Sous-enquêteur:
- Fengying Wu, MD
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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:
For inclusion in the study treatment period patients must fulfil all of the following criteria:
- Provision of informed consent.
- Male or female aged 18 years and over.
- Histologically or cytologically confirmed non-small cell lung carcinoma.
- Locally advanced Stage not amenable to local therapy (e.g. pleural effusion) or metastatic disease.
- No prior chemotherapy, biological (including targeted therapies such as Epidermal Growth Factor Receptor(EGFR) and Vascular Epidermal Growth Factor (VEGF) inhibitors) or immunological therapy. Patients who are willing to accept with paclitaxel and carboplatin as adjuvant chemotherapy will be eligible.
- World Health Organization (WHO) performance status (PS) of 0 to 2.
- Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
Laboratory values within the range, as defined below, within two weeks of randomization:
- Absolute neutrophils count(ANC)≥2.0×109/L
- Platelets≥100×109/L
- Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine tansaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases)
- Creatinine clearance≥60ml/min
- Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
- Life expectancy ≥12 weeks.
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Known severe hypersensitivity to carboplatin, paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with carboplatin / paclitaxel doublet chemotherapy.
- Prior treatment with paclitaxel.
- Current treatment with target drug and biological therapy.
- Pregnant or lactating woman.
- Prior chemotherapy, biological (including targeted therapies such as Epidermal Growth Factor Receptor(EGFR) and Vascular Epidermal Growth Factor (VEGF) inhibitors) or immunological therapy were received even if treatment was not paclitaxel and was completed in 4 weeks before day1 of study treatment.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Life expectancy of less than 12 weeks.
- Unable to tolerate carboplatin / paclitaxel doublet chemotherapy, as judged by the investigator.
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: pharmacokinetics group
Based on pharmacokinetics.
Observe safety and efficacy.
In first cycle a fixed Paclitaxel dose depends on BSA.
In subsequent cycles the dosage of Paclitaxel will be adjusted depending on pharmacokinetics follow up .
|
Based on pharmacokinetics.
Observe the toxicity in an individual patient after a fixed Paclitaxel dose depending on BSA and then the dosage of Paclitaxel is adjusted depending on pharmacokinetics follow up to avoid excess toxicity in subsequent cycles.
Based on body surface area.
The dosage of Paclitaxel is based on the BSA of the patient.
Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity.
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Comparateur actif: Body surface area(BSA) group
Based on body surface area.
The dosage of Paclitaxel is based on the BSA of the patient.
Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity.
|
Based on pharmacokinetics.
Observe the toxicity in an individual patient after a fixed Paclitaxel dose depending on BSA and then the dosage of Paclitaxel is adjusted depending on pharmacokinetics follow up to avoid excess toxicity in subsequent cycles.
Based on body surface area.
The dosage of Paclitaxel is based on the BSA of the patient.
Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
CTCAE grade 4 of the blood marrow
Délai: 24 months
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Record the number of CTCAE grade 4 of the blood marrow such as Leukocytes, Neutrophils,Platelets and Hemoglobin in two treatment groups since the initiation of chemotherapy
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24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective response rate
Délai: Tumor assessment 6-8 weeks after the initiation of chemotherapy
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The objective tumour response rate will be calculated as the percentage of evaluable patients with complete response (CR) and partial response (PR).
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Tumor assessment 6-8 weeks after the initiation of chemotherapy
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Progression free survival
Délai: 12 months
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Progression Free Survival (PFS) is defined as the time from randomization to the first documentation of objective disease progression (PD) or death from any cause.
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12 months
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Overall survival
Délai: 24 months
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Overall survival(OS) is defined as the interval between the date of randomization and the date of patient death due to any cause, or the last date the patient was known to be alive.
|
24 months
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Quality of life
Délai: 24 months
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Data on QoL will be assessed using the Functional Assessment of Cancer Therapy - Lung (FACT-L) for every patients.
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24 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Caicun Zhou, Ph.D, Tongji University Affiliated Shanghai Pulmonary Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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 des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Paclitaxel
- Paclitaxel lié à l'albumine
Autres numéros d'identification d'étude
- SPAP
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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