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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000501
Receipt No. R000000506
Scientific Title Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer
Date of disclosure of the study information 2006/10/12
Last modified on 2010/02/23

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Basic information
Public title Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer
Acronym Phase II Study of Docetaxel and TS-1 Combination Therapy for Relapsed or Refractory Non-small Cell Lung Cancer
Scientific Title Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer
Scientific Title:Acronym Phase II Study of Docetaxel and TS-1 Combination Therapy for Relapsed or Refractory Non-small Cell Lung Cancer
Region
Japan

Condition
Condition Relapsed or Refractory Non-small Cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to determine safety and efficacy in combination with docetaxel and S-1 for relapsed or refractory non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival, progression-free survival, adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Docetaxel is intravenously at 40 mg/m2 on day1, and TS-1 is orally given at 80mg/m2/day from day1 to 14 every 3weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed stage IIIB, IV, or recurrent NSCLC
2) Measurable lesions (RECIST)
3) Relapsed or refractory to prior chemotherapy or chemoradiotherapy (< 3 regimes, exclusive of postoperative Tegafur-Uracil)
4) Complete recovery from hematological adverse effct of prior therapy
5) No intrathoracic irradiation within twelve weeks or recovery from toxicity due to irradiation within twelve weeks
6) P.S.(ECOG) 0-1
7) Age ranging from 20-74 years
8) Sufficient organ functions within two weeks.
Defined as:
1. white blood cell count <=12,000/mm3
2. neutrophil count>=2000/mm3
3. platelet>=100,000/mm3
4. hemoglobin>=9.0 g/dl
5. AST and ALT within two times the upper limit of normal for the institution
6. serum bilirubin level<=1.5 mg/dl
7. serum creatinine level<=1.5 mg/dl
8. normal ECG
9. SaO2 >= 94% (room air)
9) Expected survival over 3 months
10) Possible to oral intake
11) Provided written informed consent.
Key exclusion criteria 1) Active ineterstitial pneumonitis
2) History of using TS-1 or docetaxel
3) Active infectious disease
4) Active hepatitis or hepatocirrhosis
5) Active concomitant malignancy
6) Uncontrollable diabetes
7) Serious cardiac disease
8) Psycologic illness
9) Other severe complications
10) Pleural or pericardial effusion, or ascites requiring treatment
11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
12) Regular use of warfarin
13) Regular use of fenitoin or frucitocin
14) High fever
15) Clinical symptom of brain metastases
16) Serious nephropathy and/or edema
17) Regular use of steroid
18) Medical history of serious allergy reactions to any drug
19) Inappropriate patients for this study judged by the physicians.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Yanagihara
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Shogoinkawahara-choSakyo-ku, Kyoto, Japan 606-8507
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address
TEL
Homepage URL
Email oncolctr@kuhp.kyoto-u.ac.jp

Sponsor
Institute Outpatient Oncology Unit
Kyoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 12 Day
Last modified on
2010 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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