UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000109
Receipt number R000000159
Scientific Title A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Date of disclosure of the study information 2005/09/02
Last modified on 2015/08/31 15:39:21

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Basic information

Public title

A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation
Followed by Irinotecan and Cisplatin
in Patients with Limited Small-Cell Lung Cancer

Acronym

A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation
Followed by Irinotecan and Cisplatin
in Patients with Limited Small-Cell Lung Cancer

Scientific Title

A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation
Followed by Irinotecan and Cisplatin
in Patients with Limited Small-Cell Lung Cancer

Scientific Title:Acronym

A Phase II Study of
Cisplatin, Etoposide and Concurrent Thoracic Irradiation
Followed by Irinotecan and Cisplatin
in Patients with Limited Small-Cell Lung Cancer

Region

Japan


Condition

Condition

LD-SCLC

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and the toxicity of cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by a consolidation of cisplatin and irinotecan in patients with limited-stage small-cell lung cancer in a phase II study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Two-year survival rate

Key secondary outcomes



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

Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and irinotecan

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically or cytologically confirmed limited-stage SCLC
2. No prior chemotherapy or radiotherapy
3. Measurable disease
4. ECOG performance status of 0-2
5. Age between 20 and 70 years
6. Life expectancy ≥ 3 months
7. Adequate organ funtion:
Leukocyte count from 4,000 to 12,000/mm3; hemoglobin concentration ≥9.5 g/dl; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤2 times of the upper limit of normal value; serum bilirubin ≤1.5 mg/d; serum creatinine ≤the upper limit of normal value; 24-hour creatinine clearance ≥60 ml/min; and PaO2 ≥70 torr
8. Signed informed consent

Key exclusion criteria

1. Clinically apparent interstitial pneumonitis or pulmonary fibrosis
2. Emphysema, chronic bronchitis or bronchial asthma which precludes thoracic radiotherapy
3. Malignant pleural effusion or malignant pericardial effusion
4. Active concomitant or a recent (<3 years) history of any malignancy
5. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <3 months before enrollment or congestive heart failure
6. Uncontrolled diabetes mellitus
7. Uncontrolled severe active infection
8. Intestinal paralysis or obstruction
9. Pregnancy or lactation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Saito, M.D.

Organization

Aichi Cancer Center Aichi Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan.

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address


TEL

06-6633-7400

Homepage URL


Email



Sponsor or person

Institute

West Japan 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

2005 Year 09 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=17114657

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

Completed

Date of protocol fixation

2001 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2001 Year 01 Month 01 Day

Last follow-up date

2005 Year 01 Month 01 Day

Date of closure to data entry

2005 Year 01 Month 01 Day

Date trial data considered complete

2005 Year 05 Month 01 Day

Date analysis concluded

2005 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 02 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000159


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name