UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000813 |
|---|---|
| Receipt number | R000000973 |
| Scientific Title | Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2007/09/12 |
| Last modified on | 2010/04/02 11:53:19 |
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Basic information
Public title
Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer
Acronym
Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer
Scientific Title
Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer
Scientific Title:Acronym
Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Previously treated non-small-cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and toxicity of amrubicin plus nitroglycerin regimen in third-line chemotherapy in previously treated patients with 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
Progression free survival
Key secondary outcomes
(1) response rate
(2) disease control rate
(3) Frequency of toxicities
(4) Overall survival
(5) 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 before the start of chemotherapy using 36 mg/m2 of amrubicin, D1-3, every 4 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
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, stage IV, or relapse after operation;
(c) Prior two chemotherapeutic regimens;
(d) Confirmation of progressive disease, refractory disease, or relapse after prior treatment either chemotherapy or chemoradiotherapy;
(e) A measurable or evaluable tumor lesion according to WHO criteria in CT or MRI performed within 4 weeks;
(f) Good performance status: a performance status (PS) of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
(g) Adequate hepatic function (serum bilirubin level<1.5 x LN, ALT and AST < 2.5 x LN);
(h) Adequate renal function (serum creatinine level<1.5 x LN);
(i) Adequate hematologic function (neutrophil count; equal to or more than 1,500/micro L, hemoglobin; equal to or more than 10g/dL, platelet count; equal to or more than 100,000/micro L);
(j) Adequate cardiac function (cardiothoracic ratio< 55%);
(k) Informed consent to receive chemotherapy and attend this study was obtained;
(l) Scheduled treatment with chemotherapy and without radiotherapy;
(m) Predicted prognosis equal to or more than 3 months;
Key exclusion criteria
(a) No treatment with a vasodilator such as calcium channel blockers;
(b) No treatment with nitric oxide donationg drugs;
(c) No prior chemotherapy using amrubicin;
(d) No radiotherapy to evaluable tumor lesions during this protocol treatment
(e) Without brain metastasis;
(f) No unstable ischemic heart disease;
(g) No active hepatitis;
(h) No active interstitial pneumonitis;
(i) No active hematological disease such as leukemia;
(j) No incurable duplicative cancers;
(k) No uncontrollable psychological disease;
(l) No female under nursing or pregnancy
(m) No enrollment in another interventional study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Yasuda |
Organization
Kyoto University Hospital
Division name
Division of Clinical Trial Design and Management, Translational Clinical Center/ Outpatient Oncology Unit
Zip code
Address
54 Shogoin, Kawara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4770
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Yasuda |
Organization
Kyoto University Hospital
Division name
Division of Clinical Trial Design and Management, Translational Clinical Center/ Outpatient Oncology
Zip code
Address
54 Shogoin, Kawara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4770
Homepage URL
yasuda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Division of Clinical Trial Design and Management, Translational Clinical Center, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku Univ. Hospital, Jikei Univ. Hospital, Jyuntendo Univ. Hospital, Showa Univ. Hospital, National Cancer Center Hospital East, Shinshu Univ. Hospital, Kumamoto Univ. Hospital, etc
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
| 2007 | Year | 09 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2007 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | 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
| 2007 | Year | 08 | Month | 30 | Day |
Last modified on
| 2010 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000973
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