UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011897 |
|---|---|
| Receipt number | R000013892 |
| Scientific Title | A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/03/31 09:23:12 |
* 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
A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Acronym
A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Scientific Title
A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Scientific Title:Acronym
A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Region
| Japan |
Condition
Condition
Chemo-naive patients with squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival (PFS), PFS in cases given maintenance therapy, Overall survival (OS), Maintenance extraction rates, Frequency and grade of adverse event
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-PTX 100mg/m2 (day1, 8, 15) + Carboplatin (AUC = 6, day 1) q4weeks 4cycles followed by nab-PTX 100mg/m2 (day1, 8, 15) q4weeks until disease progression
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed squamous cell lung cancer
2.Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery
3.chemo-naive
4.If 12 months or more pass, the adjuvant chemotherapy is not assumed to be a previous chemotherapy
5.The picibanil used by the pleurodesis is assumed to be registrable
6.EGFR, ALK, and MET inhibitor mono-therapy does not mean previous chemotherapy
7.The patients have not been conducted radiation therapy (Except for applied palliative radiation for the primary tumor)
8.Measurable disease
9.Age 20-74
10.ECOG performance status of 0 to 1
11.Adequate organ function, evaluated within 14 days before enrollment as;
Neu >= 1,500 /mm3
Plt >= 100,000 /mm3
hemoglobin >= 9.0 g/dL
ALT (GPT) =< 100 IU/L
T. bil =< 1.5 mg/dL
Cr >= 1.5mg/dL
SpO2 >= 95% or >= 60 torr
12.Expected to live over 3 months after administration days
13.Written informed consent from the patients
Key exclusion criteria
1.Adjuvant chemotherapy of PTX
2.Active synchronous malignancy
3.Symptomatic brain metastasis
4.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
5.>= G2 peripheral neuropathy
6.Pneumonia or Pulmonary fibrosis detectable on chest X-rays.
7.serious complication
ischemic heart disease, cardiac arrhythmia, post-MI, hepatic cirrhosis, gastrointestinal ulcer, DM
8.History of severe drug allergy
9.Women with a possibility of pregnancy, pregnant or lactating
10.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka University Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
2-15 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3833
tkijima@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka University Hospital
Division name
Dept. of Respiratory Medicine
Zip code
Address
2-15 Yamada-oka, Suita, Osaka
TEL
06-6879-3833
Homepage URL
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
OSAKA-LCSG
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 | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013892
