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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019843
Receipt No. R000018715
Scientific Title Carboplatin plus nab-Paclitaxel versus docetaxel for elderly squamous non-small cell lung cancer (CAPITAL study)
Date of disclosure of the study information 2015/11/20
Last modified on 2019/05/22

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Basic information
Public title Carboplatin plus nab-Paclitaxel versus docetaxel for elderly squamous non-small cell lung cancer
(CAPITAL study)
Acronym CBDCA+nab-PTX vs DOC for eldery Sq NSCLC Phase III study
Scientific Title Carboplatin plus nab-Paclitaxel versus docetaxel for elderly squamous non-small cell lung cancer
(CAPITAL study)
Scientific Title:Acronym CBDCA+nab-PTX vs DOC for eldery Sq NSCLC Phase III study
Region
Japan

Condition
Condition Eldery patients with advanced squamous non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of nab-paclitaxel/carboplatin with docetaxel for eldery patients with advanced squamous non-small-cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, response rate, toxicity, quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Docetaxel (60 mg/m2) given on day 1 every 3 weeks until disease progression.
Interventions/Control_2 B: Carboplatin (AUC 6) given on day1 plus nab-paclitaxel (100 mg/m2) given on day 1, 8, 15 every 3 weeks until disease progression.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed advanced squamous non-small-cell lung cancer
2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
3) Regardless of the presence of measurable lesions
4) 70 years of age or older
5) Performamne status of 0 or 1
6) Adequate organ funcion
7) life expectancy 12 weeks or more at day1
8) Written informed consent
Key exclusion criteria 1) symptomatic central nervous system metastases
2) A past hypersensitive for polysorbate or albmin
3) peripheral neuropathy CTCAE Grade 2 or more
4) uncontrolled pericardial or pleural effusion or ascites
5) prior palliative radiotherapy for metastatic lesion within 14 days before registration
6) Synchronous or metachronous active double malignancies
7) Infectious disease requiring systemic treatment or severe complications
8) do not consent to contraception
9) Positive for HBs antigen
10) positive for HBs antibody or HBc antibody, and positive for HBV-DNA
11) patients who have been judged by the invedtigator to be inappropriate in this clinical trial for other reasons
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Gemma
Organization Graduate School of Medicine,Nippon Medical School
Division name Department of Pulmonary Medicine and Oncology
Zip code
Address 1-1-5 Sendagi Bunkyoku Tokyo,Japan
TEL 03-3822-8575
Email agemma@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Ito
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Clinical Research Management, Clinical Research Center
Zip code
Address 4-1-1 Sannomaru Nakaku Nagoya, Aichi, Japan
TEL 052-951-1111
Homepage URL
Email capital.office@nnh.go.jp

Sponsor
Institute National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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
2015 Year 11 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 18 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018715

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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