UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002425 |
|---|---|
| Receipt number | R000002970 |
| Scientific Title | A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2014/03/01 09:22:08 |
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Basic information
Public title
A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer
Acronym
A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer
Scientific Title
A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer
Scientific Title:Acronym
A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
feasibility
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
feasibility
Key secondary outcomes
safety, progression-free survival
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 60mg/m2, day1 + carboplatin AUC 5mg/mLxmin, day 1
q3w, 3 cycles
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) pathologically proven non-small cell lung cancer and possible to receive chemotherapy within 4-10 weeks after surgery
2) completely resected NSCLC and pathological stage IB, II, IIIA
3) no prior chemotherapy or radiotherapy
4) PS 0 or 1
5) age 20-80
6) written informed consent
7) adequate organ function
.WBC>=4000/mm3<=12000/mm3
.neutrophil<=2000/mm3
.platelet<=100000/mm3
.AST,ALT within 2 times of upper limit
.total bilirubin <=1.5 mg/dl
.creatinin<= 1.2 mg/dl
.creatinin clearance>=60ml/min/body
PaO2>=60Torr
Key exclusion criteria
1) active infection
2) fever
3) severe complication
4) concomittant malignant cancer
5) Uncontroled pleural effusion or ascitis
6) Pericardial effusion
7) Neuropathy
8) past history of severe allergic reaction
9) Pregnant or expecting woman
10) other conditions not suitable for this study
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Hanagiri |
Organization
University
of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku,
TEL
093-691-7442
hanagiri@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetaka Uramoto |
Organization
UOEH
Division name
Second Department of Surgery
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku,
TEL
093-691-7442
Homepage URL
hidetaka@med.uoeh-u.ac.jp
Sponsor or person
Institute
University
of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University
of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
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
産業医科大学
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 01 | Day |
Last modified on
| 2014 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002970
