UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019843 |
|---|---|
| Receipt number | 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 | 2020/11/24 08:51:38 |
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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 | 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
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
capital.office@nnh.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018715
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
