UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000095
Receipt number R000000143
Scientific Title A Phase III Study Comparing Etoposide and Cisplatin (EP) with Irinotecan and Cisplatin (IP) following EP plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for the Treatment of Limited-Stage Small-Cell Lung Cancer (EP/TRT-IPIII): JCOG0202-MF
Date of disclosure of the study information 2005/08/30
Last modified on 2014/04/30 11:57:31

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Basic information

Public title

A Phase III Study Comparing Etoposide and Cisplatin (EP) with Irinotecan and Cisplatin (IP) following EP plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for the Treatment of Limited-Stage Small-Cell Lung Cancer (EP/TRT-IPIII): JCOG0202-MF

Acronym

A phase III study comparing IP with EP following EP/TRT for LD-SCLC JCOG0202-MF

Scientific Title

A Phase III Study Comparing Etoposide and Cisplatin (EP) with Irinotecan and Cisplatin (IP) following EP plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for the Treatment of Limited-Stage Small-Cell Lung Cancer (EP/TRT-IPIII): JCOG0202-MF

Scientific Title:Acronym

A phase III study comparing IP with EP following EP/TRT for LD-SCLC JCOG0202-MF

Region

Japan


Condition

Condition

Limited-Stage Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

adverse events of induction chemoradiotherapy, chemotherapy after chemoradiotherapy, late radiation morbidity, serious adverse event, progression-free survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

A: 3 courses of etoposide and cisplatin after induction chemoradiotherapy

Interventions/Control_2

B: 3 courses of irinotecan and cisplatin after induction chemoradiotherapy

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) cytologically, histologically proven small-cell lung cancer
2) limited disease
3) age 20-70 years old
4) performance status of 0-1
5) measurable disease
6) no prior treatment for small-cell lung cancer
7) no history of chemotherapy
8) adequate organ functions
9) written informed consent

Key exclusion criteria

1) pericardial effusion
2) active concomitant malignancy
3) pregnant or lactating women
4) interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.

Target sample size

270


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Nishiwaki, MD

Organization

National Cancer Center Hospital East

Division name

Thoracic Oncology Division

Zip code


Address

6-5-1 kashiwanoha Kashiwa-shi Chiba,277-8577 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kaoru Kubota, MD

Organization

JCOG0202 Coordinating Office

Division name

Thoracic Oncology Division, National Cancer Center Hospital

Zip code


Address

5-1-1 Tsukiji Chuo-ku Tokyo, 104-0045 JAPAN

TEL


Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00144989

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立病院機構北海道がんセンター(北海道)
国立病院機構道北病院(北海道)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立病院機構西群馬病院(群馬県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
癌研究会有明病院(東京都)
虎の門病院(東京都)
国立国際医療センター(東京都)
横浜市立市民病院(神奈川県)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
大阪府立成人病センター(大阪府)
国立病院機構近畿中央胸部疾患センター(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
近畿大学医学部(大阪府)
大阪市立総合医療センター(大阪府)
大阪市立大学大学院医学研究科(大阪府)
大阪府立急性期・総合医療センター(大阪府)
りんくう総合医療センター市立泉佐野病院(大阪府)
国立病院機構刀根山病院(大阪府)
兵庫県立がんセンター(兵庫県)
兵庫医科大学(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)
岡山大学医学部・歯学部附属病院(岡山県)
国立病院機構四国がんセンター(愛媛県)
熊本地域医療センター(熊本県)
九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24309370

Number of participants that the trial has enrolled


Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Main results already published

Date of protocol fixation

2002 Year 07 Month 17 Day

Date of IRB


Anticipated trial start date

2002 Year 09 Month 01 Day

Last follow-up date

2011 Year 09 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

2005 Year 08 Month 30 Day

Last modified on

2014 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name