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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004297
Receipt No. R000005152
Scientific Title Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Date of disclosure of the study information 2010/09/29
Last modified on 2015/03/29

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Basic information
Public title Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Acronym Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Scientific Title Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Scientific Title:Acronym Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Region
Japan

Condition
Condition pulmonary squamous-cellcarcinoma
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of the doublet chemotherapy (cisplatin and gemcitabine) and maintenance chemotherapy (docetaxel)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate primarily PFS of the doublet chemotherapy (cisplatin and gemcitabine) and maintenance chemotherapy (docetaxel)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 to evaluate the outcomes including PFS in the chemotherapy cosisting of cisplatin, gemcitabine and docetaxel
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

Not applicable
Gender Male and Female
Key inclusion criteria pathologically proven squamous cell carcinoma

stage IV or stage III without suitability for curative treatment

aged 20 or older

measurable tumor sites

no prior chemotherapy

no prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial

ECOG PS of 0 to 1

appropriate organ function

acquisition of written informed
consent
Key exclusion criteria pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, uncontrollable diabetes, psychlogicai diseases, hypertension, active interstitial and hearing loss.

pts with active other cancers

pts with massive pleural and cardiac effusion and ascites that need to be immediately treated

pts with symptomatic brain metastases
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikatacho, Okayama, Japan
TEL 0862237151
Email khotta@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Hotta
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikatacho, Kitaku, Okayama
TEL 0862237171
Homepage URL
Email khotta@md.okayama-u.ac.jp

Sponsor
Institute Okayama Lung Cancer Study Group
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
2010 Year 09 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2010 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 29 Day
Last modified on
2015 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005152

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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