UMIN-CTR Clinical Trial

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 Akihiko Middle name Last name Gemma
Organization	Graduate School of Medicine,Nippon Medical School
Division name	Department of Pulmonary Medicine and Oncology
Zip code	113-8602
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 Yutaka Middle name Last name Ito
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Clinical Research Management, Clinical Research Center
Zip code	460-0001
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	National Hospital Organization Nagoya Medical Center
Address	4-1-1 Sannomaru Nakaku Nagoya, Aichi, Japan
Tel	052-951-1111
Email	capital.office@nnh.go.jp

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	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 10 Day
Date trial data considered complete	2021 Year 01 Month 15 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 18 Day
Last modified on	2020 Year 11 Month 24 Day

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