AzTrials
AzTrials

Lung NeoplasmsPhase 3TFINENCT01038661

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

A Phase 3 study testing Docetaxel and Cisplatin in people with Lung Neoplasms, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Neoplasms
What is being tested?
Docetaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteChina
Study dates
Nov 2009to Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sanofi-Aventis Administrative Office

    Shanghai

Other trials in China

About this study

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

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.
Read the 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
Being tested
Docetaxel, Cisplatin, Best supportive care (BSC)
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere®

    Formulation: concentrated solution for intravenous infusion (IV)

    Route(s) of administration: 1-hour IV

  • CisplatinDrug

    Formulation: concentrated solution for intravenous infusion (IV)

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

  • Best supportive care (BSC)Other

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

Study groups in NCT01038661
Study groupRoleWhat they receive
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²ExperimentalDocetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Receives: Drug: Docetaxel; Drug: Cisplatin
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²ExperimentalDocetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Receives: Drug: Docetaxel; Drug: Cisplatin
Maintenance treatment: docetaxel (60 mg/m2)ExperimentalDocetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Receives: Drug: Docetaxel
Maintenance treatment: best supportive care (BSC)Active comparatorBSC until progressive disease
Receives: Other: Best supportive care (BSC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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 outcomes (4)

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

    Measured: Every 2 cycles (6 weeks)

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

    Measured: Every 2 cycles (6 weeks)

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

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

  4. Overall survival (OS)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01038661
Sponsor's protocol ID
DOCET_L_04827
Acronym
TFINE
Status last verified
Feb 2014
First submitted
22 Dec 2009
Last updated
28 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33708965

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and Cisplatin in people with Lung Neoplasms, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01038661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in