- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Shanghai, Kina
- Sanofi-Aventis Administrative Office
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
Andre navn:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Eksperimentell: 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
Andre navn:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Eksperimentell: 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
Andre navn:
|
Aktiv komparator: Maintenance treatment: best supportive care (BSC)
BSC until progressive disease
|
Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progression-free survival (PFS) during the maintenance treatment phase
Tidsramme: 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)
|
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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Disease control rate (DCR) during the first line treatment phase
Tidsramme: Every 2 cycles (6 weeks)
|
Every 2 cycles (6 weeks)
|
Overall response rate (ORR) during the first line treatment phase
Tidsramme: Every 2 cycles (6 weeks)
|
Every 2 cycles (6 weeks)
|
Time to disease progression (TTP) during the maintenance treatment phase
Tidsramme: 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)
Tidsramme: 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)
|
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)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DOCET_L_04827
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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