- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Shanghai, China
- Sanofi-Aventis Administrative Office
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
Other Names:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Experimental: 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
Other Names:
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
Experimental: 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
Other Names:
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS) during the maintenance treatment phase
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease control rate (DCR) during the first line treatment phase
Time Frame: Every 2 cycles (6 weeks)
|
Every 2 cycles (6 weeks)
|
Overall response rate (ORR) during the first line treatment phase
Time Frame: 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
Time Frame: From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
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From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
|
Overall survival (OS)
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOCET_L_04827
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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