UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011315 |
|---|---|
| Receipt number | R000013259 |
| Scientific Title | The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance |
| Date of disclosure of the study information | 2013/09/05 |
| Last modified on | 2020/03/24 17:29:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in
Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Acronym
The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in
Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Scientific Title
The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in
Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Scientific Title:Acronym
The Feasibility Study of Adjuvant nab-paclitaxel+Carboplatin in
Patients with Resected Stage IB-IIIA Non-Small-Cell Lung Cance
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of nab-paclitaxel+Carboplatin as adjuvant chemotherapy in patients with completely resected stage IB-IIIA non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Accomplishment of 4 course treatment
Key secondary outcomes
2yr RFS,OS,RDI,Safty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8,15 every 4weeks.
Carboplatin AUC 5 is administered by an infusion lasting 30-60 minutes on day 1 following to nab-paclitaxel every 4 weeks for 4 courses
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically determined non-small cell lung cancer Completely resected
2) Pathological stageIB, IIA, IIB, IIIA
3) at least lobectomy and LN dissection (ND2a) or Elective Lymph Node Dissection
4) Completely resected
5) Neither previous chemotherapy nor radiotherapy before operation
6) ECOG performance status 0 or 1
7) Aged 20-80 years old
8) days before enrollment
*Neutrophil count >= 1,500 /mm3
*Platelet count >= 100,000 /mm3
*Hemoglobin >= 9.0 g/dL
*total bilirubin <or= 1.5 mg/dL
*AST and ALT x 2.5 of upper limit of
normal (ULN) or les
*Serum creatinine <= 1.5 mg/dL
9) Normal electocardiogram
10) Patients are excepted to live at least 3 months
11) Possible to receive chemotherapy within 8 months after surgery
12) Written informed consent
Key exclusion criteria
1) Allergy for CBDCA/nab-paclitaxel
2) History of Severe drug allergies
3) Myocardial infarction within 6 months
4) Interstitial pneumonia or pulmonary fibrosis detectable on X ray
5)Severe concurrent disease (Ischemic heart disease requiring treatment,arrhythmia,cardiac infarction within 6months before enrollment,hepatic failure,hemorrhagic peptic ulcer,poorly controlled diabetes)
6) History of active double cancerwithin 5years prior to the study
7) HBV-positive patients
8) Patients who are pregnant,considering pregnancy oractaing
9) Other conditions not suitable forthis study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihito Okada |
Organization
Hiroshima University
Division name
Surgical Oncology
Zip code
Address
1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyata |
Organization
Hiroshima University
Division name
Surgical Oncology
Zip code
Address
Minami-ku, Hiroshima,Japan
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 09 | Month | 05 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013259
