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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002425
Receipt No. 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

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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
Email 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
Email hidetaka@med.uoeh-u.ac.jp

Sponsor
Institute University
of Occupational and Environmental Health
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002970

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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