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

Primary Purpose

Lung Neoplasms

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel

Cisplatin

Best supportive care (BSC)

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²

First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²

Maintenance treatment: docetaxel (60 mg/m2)

Maintenance treatment: best supportive care (BSC)

Arm Description

Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles

BSC until progressive disease

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) during the maintenance treatment phase

Secondary Outcome Measures

Disease control rate (DCR) during the first line treatment phase

Overall response rate (ORR) during the first line treatment phase

Time to disease progression (TTP) during the maintenance treatment phase

Overall survival (OS)

Full Information

NCT ID

NCT01038661

First Posted

December 22, 2009

Last Updated

February 27, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01038661

Brief Title

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

Acronym

TFINE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

375 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²

Arm Type

Experimental

Arm Description

Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Arm Title

First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²

Arm Type

Experimental

Arm Description

Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Arm Title

Maintenance treatment: docetaxel (60 mg/m2)

Arm Type

Experimental

Arm Description

Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles

Arm Title

Maintenance treatment: best supportive care (BSC)

Arm Type

Active Comparator

Arm Description

BSC until progressive disease

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere®

Intervention Description

Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV

Intervention Type

Other

Intervention Name(s)

Best supportive care (BSC)

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Disease control rate (DCR) during the first line treatment phase

Time Frame

Every 2 cycles (6 weeks)

Title

Overall response rate (ORR) during the first line treatment phase

Time Frame

Every 2 cycles (6 weeks)

Title

Time to disease progression (TTP) during the maintenance treatment phase

Time Frame

From 2nd randomization up to disease progression (every 2 cycles (6 weeks))

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Shanghai

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33708965

Citation

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.

Results Reference

derived

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

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