UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012903 |
|---|---|
| Receipt number | R000015079 |
| Scientific Title | Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/10/24 11:02:31 |
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Basic information
Public title
Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.
Acronym
Randomized phase II study of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1.
Scientific Title
Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.
Scientific Title:Acronym
Randomized phase II study of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1.
Region
| Japan |
Condition
Condition
squamous cell carcinoma of the lung
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival(PFS)
Key secondary outcomes
quality of life(QOL)
response rate(RR)
disease control rate(DCR)
overall survival(OS)
maintenance therapy shift rate
PFS from the start of maintenance therapy
adverse events(AEs)
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 not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nab-PTX plus CBDCA followed by maintenance nab-PTX.
Interventions/Control_2
TS-1 plus CBDCA followed by maintenance TS-1.
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 confirmed squamous cell lung cancer.
2.Stage IIIB/IV without indication for radical thoracic irradiation or postoperative recurrence.
3.No prior chemotherapy or postoperative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy.
4.Age > or = 20 years
5.Eastern Cooperative Oncology Group performance status of 0-1
6.Tumor has the Measurable lesion.
7.Adequate organ function, Adequate organ function within 2 weeks
7-1:Leukocyte count > or = 3,000/mm3
7-2:Neutrophil count > or = 1,500/mm3
7-3:Hemoglobin > or = 9.0 g/dl
7-4:Platelet count > or = 100,000/mm3
7-5:Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L
7-6:Total bilirubin < or = 1.5 mg/dl
7-7:Serum creatinine < or = 1.2 mg/dl
7-8:Creatinine clearance; > or = 60mL/min
7-9:Acceptable cardiac function
7-10:Peripheral neuropathy < or = grade 1
8.Estimating Survival more than 3 months.
9.Capable of oral intake
10.Written informed consent from the patients.
Key exclusion criteria
1.History of hypersensitivity to drugs or albumin.
2.Severe infection
3.Significant comorbid disease (paresis of intestine, ileus, GI bleeding, uncontrolled angina pectoris, cardiac disease, etc)
4.Massive pleural and cardiac effusion and ascites required for tube drainage.
5.Cases of administration in the flucytosine.
6.Patients with superior vena cava syndrome.
7.Active synchronous malignant neoplasm.
8.Interstitial pneumonia or pulmonary fibrosis detectable on Chest X ray.
9.Brain metastases patients in need of treatment, such as an anti-seizure medication and steroids or have symptoms.
10.Cases of post-radiation to the primary tumor.
11.Cases of palliative bone or brain irradiation within two weeks of proposed entry to this study.
12.Uncontrolled psychiatric disease.
13.Pregnancy, breast feeding and suspected pregnancy.
14.Other conditions not suitable for this study.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
Internationanl University of Health and Welfare
Division name
Respiratory Disease center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
snagase@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
Internationanl University of Health and Welfare
Division name
Respiratory Disease center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
Homepage URL
snagase@iuhw.ac.jp
Sponsor or person
Institute
Internationanl University of Health and Welfare, Respiratory Disease center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
慶応義塾大学病院 呼吸器内科 (東京都）
国立国際医療研究センター 呼吸器内科 (東京都）
災害医療センター 呼吸器内科 (東京都）
聖路加国際病院 呼吸器内科 (東京都）
帝京大学医学部附属病院 呼吸器・アレルギー内科 (東京都）
東京女子医科大学病院 呼吸器内科 (東京都）
東京医科大学病院 呼吸器・甲状腺外科 (東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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 | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | 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 | 01 | Month | 20 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015079
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