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


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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name