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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012903
Receipt No. 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

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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
Email 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
Email snagase@iuhw.ac.jp

Sponsor
Institute Internationanl University of Health and Welfare, Respiratory Disease center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015079

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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