UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005816 |
|---|---|
| Receipt number | R000006876 |
| Scientific Title | A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2021/02/18 22:57:46 |
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Basic information
Public title
A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
Acronym
A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
Scientific Title
A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
Scientific Title:Acronym
A phase I/II study of Cisplatin, Amrubicin plus irradiation for Limited disease small cell lung cancer
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective of this study to investigate efficacy and safety for limited disease small cell lung cancer with chemoradiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression Free Survival
Overall survival
Toxicity
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
Amurubicin/Cisplatin plus irradiation
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Histological or cytological diagnosis of lung cancer
(2)untreated patient
(3)Limited disease
(4)Patients without active double cancer
(5)Age 70 years or younger
(6)ECOG Performance status :0-1
(7)Patients with adequate organ function
WBC 4000/mm3 or more,Hb 10.0g/dl,Plt 100000/mm3 more,T. Bil 1.5mg/dl or less
,AST,ALT 2 times the upper limit of normal for the facility,sCr<the upper limit of normal for the facility
(8)Provided written consent in person for participation in this study
Key exclusion criteria
(1)stage IA
(2)accumulated cardiac effusion
(3)accumulated pleural effusion
(4)Patients with active severe infections
(5)Women during pregnancy
(6)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Shimada |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
7-1 Sakamoto-1, Nagasakishi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
TEL
095-819-7273
Homepage URL
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
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
| 2011 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Eight patients were enrolled at three dose levels. Two of two patients in 30 mg/m2 dose level experienced DLTs. The presentation of DLTs included grade4 neutropenia and leukopenia lasting more than four days. Evaluation of responses were 7 partial response and 1 progressive disease (response rate 87.5%). The MTD of amrubicin and cisplatin were determined as 30 mg/m2 and 60 mg/m2. A dose of 25 mg/m2 amrubicin and cisplatin 60 mg/m2 was recommended in this regimen.
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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006876
