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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004127
Receipt No. R000004957
Scientific Title A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Date of disclosure of the study information 2010/08/30
Last modified on 2018/03/07

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Basic information
Public title A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Acronym A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Scientific Title A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Scientific Title:Acronym A phase II trial of cisplatin, docetaxel and bevacizumab followed by maintenance pemetrexed and bevacizumab in metastatic non-small-cell lung cancer
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

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

Assessment
Primary outcomes PFS
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 cisplatin, docetaxel, bevacizumab, and pemetrexed
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria pathologically proven non-squamous cell carcinoma
stage IV or ineligibility
as candidates for curative treatment
aged 75 or less
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
no prior thoracic irradiation to primary tumor
no prior operation within 4 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 hemoptysis with 2.5mL or more
bleeding tendency
pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion
pts with bleeding tendency
pts who need continuous use of antithrombotic agents
pts with active other cancers that was detected within the past 5 years
pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
pregnant women
pts who need emergent irradiation
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, Okayama, Japan
TEL 0862237151
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 08 Month 30 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 Main results already published
Date of protocol fixation
2010 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 08 Month 30 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004957

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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