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
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/
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
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
