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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000705
Receipt No. R000000841
Scientific Title Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Date of disclosure of the study information 2007/05/14
Last modified on 2009/10/21

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Basic information
Public title Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Acronym Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Scientific Title Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Scientific Title:Acronym Phase II trial of gemcitabine and cisplatin in patients with completely resected stage IB-IIIA non-small-cell lung cancer.
Region
Japan

Condition
Condition in patients with completely resected stage IB-IIIA non-small-cell
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 treatment compliance
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes treatment compliance rate is 70% or more.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients completely resected p-stage IB-IIIA non&#8211;small-cell lung cancer with acceptable baseline characteristics and an ECOG performance status of 0 or 1 were eligible
Key exclusion criteria Patients with incomplete resection, wedge resection, clinically significant cardiac dysfunction, active infection, Varicella, or critical complications, neurologic or psychiatric disorders, and patients who had had other cancers treated within the previous five years were ineligible. Pregnant woman were also ineligible. Patients decided to be unsuitable by the doctor was ineligible.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Suzuki
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1 Handayama, Higashi, Hamamatsu, 431-3192,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhito Funai
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address
TEL
Homepage URL
Email kfunai@hmedc.or.jp

Sponsor
Institute First Department of Surgery
Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Nothing
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
2007 Year 05 Month 14 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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2008 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2007 Year 05 Month 02 Day
Last modified on
2009 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000841

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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