UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Nagasaki Thoracic Oncology Group
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006876