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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001820
Receipt No. R000002194
Scientific Title Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer
Date of disclosure of the study information 2009/03/31
Last modified on 2010/04/02

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Basic information
Public title Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer
Acronym Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer (TUTRCDC003)
Scientific Title Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer
Scientific Title:Acronym Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer (TUTRCDC003)
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the effects and toxicity of nitroglycerin plus docetaxel in elderly patients with advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes (1) response rate
Key secondary outcomes (1) Progression free survival
(2) Frequency of toxicities
(3) Overall survival
(4) Change in plasma vascular endothelial growth factor level during nitroglycerin treatment for 3 days before chemotherapy as an indicator for response to nitroglycerin plus docetaxel and cisplatin regimen

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Transdermally applied nitroglycerin (10 mg/day) for consecutive 5 days between 3 days before start of chemotherapy using 60 mg/m2 of docetaxel (D1) every 3 weeks and the day 2 of chemotherapy
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
70 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria (a) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination;
(b) Stage IIIB or stage IV;
(c) A measurable or evaluable tumor lesion according to WHO criteria;
(d) Good performance status: a performance status (PS) of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
(e) Adequate hepatic function (serum bilirubin < 1.5 x LN, ALT, and AST < 2.5 x LN);
(f) Adequate hematologic function (neutrophil count > 2,000/&micro;L, hemoglobin > 9g/dL, platelet count> 100,000/&micro;L);
(g) Adequate cardiac function (cardiothoracic ratio< 60%);
(h) Informed consent to receive chemotherapy and attend this study was obtained;
(i) Scheduled treatment with chemotherapy and without radiotherapy;
(j) Systolic blood pressure: equal to or more than 90mmHg
(k) Prognosis: equal to or more than 3 months
Key exclusion criteria (a) No treatment with a vasodilator such as calcium channel blockers
(b) No prior chemotherapy or radiotherapy;
(c) Without uncontrollable brain metastasis;
(d) No ischemic heart disease;
(e) Without active interstitial pneumonitis
(f) Without uncontrollable massive pleural effusion or pericardial effusion
(g) Without pregnancy or nurse
(h) No enrollment in another interventional study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Yasuda
Organization Tohoku University Translational Research Center
Division name Department of clinical application
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7122
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Yasuda
Organization Tohoku University Translational Research Center
Division name Department of clinical application
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7122
Homepage URL
Email yasuda@trc.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Translational Research Center
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government, and The Kanae Foundation for the Promotion of Medical Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tohoku University Hospital, Shinshu University Hospital, Shiga Medical Center for Adults, Kyoto University Hospital, Osaka Police Hospital, Takatsuki Red Cross Hospital
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 31 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
Date of protocol fixation
2009 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 30 Day
Last modified on
2010 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002194

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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