- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01038661
Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy (TFINE)
Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel (60mg/m2)Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel(75/60mg/m2)in Combination With Cisplatin in Patients With Local Advanced or Metastatic (Stage IIIB/IV)Non-Small Cell Lung Cancer
The Primary Objective is to evaluate the progression-free survival (PFS).
The secondary objectives are:
- To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;
- To evaluate the overall response rate (ORR);
- To evaluate the time to disease progression (TTP);
- To evaluate the overall survival (OS);
- To evaluate the toxicity.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study consists in:
- A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,
- A maintenance treatment phase: participants with disease control (complete response [CR], partial response [PR] or stable disease [SD]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).
- A follow-up period from the end of study treatment until participant death or end of study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Shanghai, Cina
- Sanofi-Aventis Administrative Office
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- Histologic or cytologic diagnosis of advanced non-small-cell lung cancer (NSCLC)
- Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastasis (TNM) stage criteria of lung cancer, local advanced stage IIIB (not applicable for radical radiation therapy) disease or metastatic stage IV disease or recurrent disease
- At least one evaluable tumor lesion based on RECIST criteria (>= 20 mm with conventional techniques or >= 10 mm with spiral Computed Tomography scan)
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1
Adequate bone marrow reserve
- absolute neutrophil count >= 2.0×10^9/L
- platelets >= 100×10^9/L
- hemoglobin >= 9.0 g/dL
Adequate hepatic function
- total bilirubin <= Upper Normal Limit (UNL)
- Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) <= 2.5 UNL
- alkaline phosphatase (ALP) <= 5 UNL
- Adequate renal function (serum creatinine <= UNL or creatinine clearance >= 60 mL/min)
- No prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²)
- Prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery
- Childbearing potential either terminated or attenuated by the use of an approved contraceptive method
- Inform consent signed
Exclusion criteria:
- Other tumour type than advanced / metastatic NSCLC in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin).
- Presence of symptomatic central nervous system metastases
Inadequate liver function
- total bilirubin > 1 UNL
- ALT and/or AST>1.5 UNL associated with alkaline phosphatase > 2.5 UNL
- inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, creatinine clearance < 60 mL/min)
- Prior radiation therapy, or surgery operation within 4 weeks
- Prior use of taxoids
- Active infection, or serious concomitant systemic disorder incompatible with the study
- Childbearing potential but unwilling to use of an approved contraceptive method
- Receive treatment from other clinical trials during this study treatment
- History of hypersensitivity to any of study medication
- Other serious concomitant abnormal or illness
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
|
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
Altri nomi:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Sperimentale: First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
|
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
Altri nomi:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Sperimentale: Maintenance treatment: docetaxel (60 mg/m2)
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
|
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
Altri nomi:
|
Comparatore attivo: Maintenance treatment: best supportive care (BSC)
BSC until progressive disease
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Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Progression-free survival (PFS) during the maintenance treatment phase
Lasso di tempo: From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
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From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Disease control rate (DCR) during the first line treatment phase
Lasso di tempo: Every 2 cycles (6 weeks)
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Every 2 cycles (6 weeks)
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Overall response rate (ORR) during the first line treatment phase
Lasso di tempo: Every 2 cycles (6 weeks)
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Every 2 cycles (6 weeks)
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Time to disease progression (TTP) during the maintenance treatment phase
Lasso di tempo: From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
|
From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
|
Overall survival (OS)
Lasso di tempo: From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
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From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Neoplasie polmonari
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Docetaxel
- Cisplatino
Altri numeri di identificazione dello studio
- DOCET_L_04827
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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