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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013223
Receipt No. R000015432
Scientific Title A Phase I Study of Carboplatin and nab-Paclitaxel plus concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Date of disclosure of the study information 2014/02/22
Last modified on 2020/02/29

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Basic information
Public title A Phase I Study of Carboplatin and nab-Paclitaxel plus concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Acronym Phase I study of CBDCA+nab-PTX+TRT with locally advanced NSCLC
Scientific Title A Phase I Study of Carboplatin and nab-Paclitaxel plus concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
Scientific Title:Acronym Phase I study of CBDCA+nab-PTX+TRT with locally advanced NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To determine the recommended dose of concurrent chemoradiotherapy with Carboplatin and nab-Paclitaxel for untreated locally advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Estimation of the recommended dose, evaluation of dose-limiting toxicity
Key secondary outcomes safety and efficacy

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 Patients receive CBDCA (AUC 2) and nab-paclitaxel (35, 40, 45mg/m2) on day 1 every weeks with concurrent thoracic radiation therapy.
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 1) histologically or cytologically comfirmed non-small cell lung cancer
2) patient has an indication for concurrent chemoradiotherapy.
3) ECOG performance status of 0-2
4) patients aged 20 years or older
5) adequate bone marrow, liver, and renal functions 2weeks prior to registration:
neutorophil >=1,500/mm3; platelet >=100,000/mm3; AST and ALT < 5x of upper limit of normal (ULN); total bilirubin <=1.5mg/mL; serum creatinin <=1.5 mg/dl; SpO2>90
6) a life expectancy of 3 months or more
7) written informed consent
Key exclusion criteria 1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-induced lung damage
2) complicated by infectious disease requiring intravenous administration of antifungal agents and/or antibacterial agents
3) active double cancer
4) Patients with problematic complication(s) (ex. uncontrol heart disease, serious arrhythmia)
5) pregnant or lactating women or those who declined contraception
6) Patients with severe mental illness
7) Unsuitable patients judged by the attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Akihito
Middle name
Last name Yokoyama
Organization Kochi University, School of Medicine
Division name Dept of Hematology and Respiratory Medicine
Zip code 783-8505
Address Kohasu, Okocho, Nankoku city, Kochi
TEL 088-880-2345
Email im25@kochi-u.ac.jp

Public contact
Name of contact person
1st name Tetsuya
Middle name
Last name Kubota
Organization Kochi University, School of Medicine
Division name Dept of Hematology and Respiratory Medicine
Zip code 783-8505
Address Kohasu, Okocho, Nankoku city, Kochi
TEL 088-880-2345
Homepage URL
Email kubotat@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization Kochi University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kochi Univeersity
Address Kohasu,Oko-cho,Nankoku-shi,Kochi
Tel 088-880-2719
Email im62@kochi-u.ac.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
2014 Year 02 Month 22 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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 14 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
2014 Year 02 Month 22 Day
Last modified on
2020 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015432

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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