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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001755
Receipt No. R000002113
Scientific Title Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer
Date of disclosure of the study information 2009/03/05
Last modified on 2017/03/09

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Basic information
Public title Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer
Acronym Prophylactic cranial irradiation for ED-SCLC
Scientific Title Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer
Scientific Title:Acronym Prophylactic cranial irradiation for ED-SCLC
Region
Japan

Condition
Condition Extensive small-cell lung cancer patients with no brain metastasis who had a response to platinum-based first-line chemotherapy,
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this trial is to evaluate the effects of prophylactic cranial irradiation on overall survival, brain metastases and late toxic effects in extensive small-cell lung cancer patients with no brain metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Incidence of brain metastasis, Time to brain metastasis, Progression free survival, Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Prophylactic cranial irradiation 25Gy
(2.5 Gy X 10frs)
Interventions/Control_2 No therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. 20 years of age or older
2. PS(ECOG)0-2
3. Documented extensive smallcell lung cancer
4. Response after at least 2 cycles of initial platinum-based chemotherapy.
5. No brain metastasis detected by brain MRI before randomization
6. An interval of no more than 6 weeks
between the start of the last cycle of chemotherapy and randomization
7. Written informed consent
Key exclusion criteria 1. Previous radiotherapy to the head and neck area overlapped with PCI field.
2. Another active cancer
3. Serious psychological and/or physiological complications
4. An expectant or lactating woman
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Wakayama Medical University
Division name Third department of Internal Medicine
Zip code
Address 811-1, Kimiidera,Wakayama City,Wakayama, 641-8509, Japan
TEL 073-441-0619
Email nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Takahashi
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777
TEL 055-989-5222
Homepage URL
Email t.takahashi@scchr.jp

Sponsor
Institute Yamamoto Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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 1.岡山大学医学部・歯学部附属病院
2.公立学校共済組合中国中央病院
3.住友別子病院
4.国家公務員共済組合連合会浜の町病院
5.KKR札幌医療センター
6.横浜市立市民病院
7.麻生飯塚病院
8.広島市民病院
9.国立病院機構山口宇部医療センター
10.国立病院機構北海道がんセンター
11. 兵庫県立がんセンター
12.仙台厚生病院
13.近畿大学医学部附属病院
14.神奈川県立循環器呼吸器病センター
15.新潟大学医歯学総合病院
16.大阪府立呼吸器・アレルギー医療センター
17.群馬県立がんセンター
18.新潟県立がんセンター新潟病院
19.北海道大学病院
20.神戸大学医学部附属病院
21.宮城県立がんセンター
22.国立病院機構 道北病院
23.国立病院機構九州がんセンター
24.先端医療センター
25.国立病院機構西群馬病院
26.国立病院機構名古屋医療センター
27. 癌研究会有明病院
28.愛知県がんセンター中央病院
29.大阪市立総合医療センター
30.旭川医科大学病院
31.静岡県立静岡がんセンター
32.倉敷中央病院
33.熊本地域医療センター
34.厚生連高岡病院
35.名古屋市立大学病院
36.北里大学医学部付属病院
37.福島県立医科大学病院
38.埼玉県立がんセンター
39.国立病院機構近畿中央胸部疾患センター
40.順天堂大学医学部付属病院
41.茨城県立中央病院
42.岐阜市民病院
43.東北大学病院
44.兵庫医科大学病院
45.国立がんセンター中央病院
46.国立がんセンター東病院
47.九州大学病院
48.都立駒込病院
49. 栃木県立がんセンター
50.熊本大学医学部付属病院
51.四国がんセンター
52.津山中央病院

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 05 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
PCI does not prolong overall survival in extensive-disease small-cell lung cancer patients.
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
2009 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2017 Year 02 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
2009 Year 03 Month 04 Day
Last modified on
2017 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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