UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000828 |
|---|---|
| Receipt number | R000000990 |
| Scientific Title | A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605) |
| Date of disclosure of the study information | 2007/09/20 |
| Last modified on | 2013/03/26 16:59:27 |
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Basic information
Public title
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)
Acronym
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)
Scientific Title
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)
Scientific Title:Acronym
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)
Region
| Japan |
Condition
Condition
Sensitive relpased small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate survival benefit comparing irinotecan, cisplatin and etoposide (PEI) with nogitecan for sensitive relapsed small-cell lung cancer
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
progression-free survival, adverse events, response rate
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 |
Interventions/Control_1
A: nogitecan (1.0 mg/m2/day) on days 1 through 5 every 3 weeks, for 4 courses
Interventions/Control_2
B: irinotecan, cisplatin and etoposide (PEI)
1 course (2 weeks) consisted of cisplatin (25 mg/m2, day1, 8), etoposide (60 mg/m2, day1-3), and irinotecan (90 mg/m2, day8), for 5 courses. After day 8, granulocyte colony-stimulating factor (G-CSF) is administered routinely on days when the cytotoxic drugs are not given.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) histologically or cytologically confirmed small-cell lung cancer
2) received first-line chemotherapy or chemoradiotherapy with platinum-based regimen
3) underwent no operation of small-cell lung cancer
4) relapsed more than 90 days after the completion of first-line treatment
5) pathologically confirmed local relapse of small-cell lung cancer, if it was difficult to distinguish from radiation pneumonitis
6) responded to first-line chemotherapy or chemoradiotherapy (CR or PR)
7) performance status of 0-2 on the Eastern Cooperative Oncology Group scale
8) age from 20 to 75 years
9) unnecessary to have measurable disease
10) adequate organ function
(1) WBC >= 3,000 /mm3
(2) Neutrophil >= 1,500 /mm3
(3) Hemoglobin >= 9.0 g/dL
(4) Platelet >= 100,000 /mm3
(5) Total serum bilirubin <= 2.0 mg/dL
(6) GOT (AST) <= 100 IU/L
(7) GPT (ALT) <= 100 IU/L
(8) Serum creatinine <= 1.5 mg/dL
(9) PaO2 >= 70 torr
11) written informed consent
Key exclusion criteria
1) no active concomitant malignancy
2) pregnancy or lactation
3) serious psychiatric illness
4) steroid treatment
5) massive pleural or pericardial effusion
6) symptomatic brain metastasis
7) interstitial pneumonia or severe pulmonary emphysema
8) diarrhea
9) ileus
10) myocardial infarction within 6 months or unstable angina
11) uncontrollable hypertension
12) uncontrollable diabetes mellitus
13) active infection
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Nishiwaki |
Organization
National Cancer Center Hospital East
Division name
Thoracic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Goto |
Organization
JCOG0605 Coordinating Office
Division name
National Cancer Center Hospital East, Thoracic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構旭川医療センター（北海道）
国立病院機構北海道がんセンター（北海道）
ＫＫＲ札幌医療センター（北海道）
宮城県立がんセンター（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）
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
がん感染症センター都立駒込病院（東京都）
国立国際医療研究センター病院（東京都）
がん研究会有明病院（東京都）
順天堂大学医学部付属順天堂医院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
横浜市立市民病院（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）
国立病院機構名古屋医療センター（愛知県）
愛知県がんセンター愛知病院（愛知県）
大阪市立大学医学部附属病院（大阪府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター（大阪府）
国立病院機構近畿中央胸部疾患センター（大阪府）
大阪市立総合医療センター（大阪府）
兵庫県立がんセンター（兵庫県）
倉敷中央病院（岡山県）
岡山大学病院（岡山県）
国立病院機構山口宇部医療センター（山口県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
熊本地域医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2007 | Year | 09 | Month | 20 | Day |
Last modified on
| 2013 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000990
