Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

NCT ID: NCT01038661

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-08-31

Brief Summary

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.

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.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Cisplatin

Intervention Type: DRUG

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-3-hour IV

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Cisplatin

Intervention Type: DRUG

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-3-hour IV

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Maintenance treatment: best supportive care (BSC)

BSC until progressive disease

Group Type: ACTIVE_COMPARATOR

Best supportive care (BSC)

Intervention Type: OTHER

Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator

Interventions

Docetaxel

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Intervention Type: DRUG

Cisplatin

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-3-hour IV

Intervention Type: DRUG

Best supportive care (BSC)

Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator

Intervention Type: OTHER

Other Intervention Names

Taxotere®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Shanghai, , China

Countries

China

References

Zhang L, Lu S, Cheng Y, Hu Z, Wu YL, Chen Z, Chen G, Liu X, Yang J, Zhang L, Chen J, Huang M, Tao M, Cheng G, Huang C, Zhou C, Zhang W, Zhao H, Sun Y. Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial. Ann Transl Med. 2021 Feb;9(4):338. doi: 10.21037/atm-20-8078.

Reference Type: DERIVED

PMID: 33708965 (View on PubMed)

Other Identifiers

DOCET_L_04827

Identifier Type: -

Identifier Source: org_study_id