UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013223 |
|---|---|
| Receipt number | 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 | 2024/01/05 13:54:24 |
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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
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
kubotat@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://iv.iiarjournals.org/content/38/1/259
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 06 | Day |
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
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015432
