UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000501 |
|---|---|
| Receipt number | 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 12:18:47 |
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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
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
oncolctr@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Outpatient Oncology Unit
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000506
