UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)
Acronym	Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)
Scientific Title	Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)
Scientific Title:Acronym	Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)
Region	Japan

Condition
Condition	limited disease small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of CODE or 'Amrubicin plus cisplatin' chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy, and to select the promising arm for subsequent phase III trials
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival rate at one-year from 2nd registration
Key secondary outcomes	Response rate, complete response rate, overall survival , progression-free survival , and incidences of adverse event, grade 4 non-hematological toxicit, early death, and treatment-related death

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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: etoposide 100mg/m2 days 1-3, cisplatin 80mg/m2 day 1, and thoracic radiotherapy 45Gy/30 fractions, followed by three cycles of cisplatin 25mg/m2 days 1, 8, vincristine 1mg/m2 day 8, doxorubicin 40mg/m2 day 1, and etoposide 80mg/m2 days 1-3. Prophylactic cranial irradiation 25Gy/10 fractions for patients with CR.
Interventions/Control_2	B: etoposide 100mg/m2 days 1-3, cisplatin 80mg/m2 day 1, and thoracic radiotherapy 45Gy/30 fractions, followed by three cycles of cisplatin 60mg/m2 day 1, and amrubicin 40mg/m2 days 1-3. Prophylactic cranial irradiation 25Gy/10 fractions for patients with CR.
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) a histological or cytological diagnosis of small cell lung cancer 2) limited disease and clinical stage II-III 3) age between 20 and 70 years old 4) ECOG performance status of 0-1 5) having a measurable disease 6) the first treatment for small cell lung cancer 7) no prior chemothearpy or thoracic radiotherapy for any malignancies 8) a radiation oncologist determines that radiothearpy is possible 9 ) adequate organ functions defined as indicated below; i) WBC of 4,000/mm3 or more ii) Hemoglobin of 9.0 g/dL or more iii) Platelet of 100,000/mm3 or more iv) Total serum bilirubin of 1.5 mg/dL or less v) GOT (AST) of 100 IU/L or less vi) GPT (ALT) of 100 IU/L or less vii) Serum creatinine of 1.3 mg/dL or less viii) PaO2 of 70 torr or more at room air 10) written informed consent
Key exclusion criteria	1) synchronous or metachronous active malignancies 2) allergy to a contrast agent 3) any of the followings: i) inappropriate secretion of antidiuretic hormone (SIADH) ii) ectopic ACTH syndrome iii) Lambert-Eaton myasthenic syndrome iv) subacute cerebellar degeneration v) paraneoplastic encephalomyelitis / sensory neuropathy 4) infection requiring systemic treatment 5) fever of 38 degrees centigrade or higher within 24 hours before registration 6) pregnant or lactating women 7) psychotic disorder 8) receiving systemic steroid therapy 9) unstable angina or myocardial infarction within the past 6 months 10) uncontrolled hypertension 11) uncontrolled diabetes mellitus or administration of insulin 12) interstitial pneumonitis or lung fibrosis identified by a chest X-ray, or severe pulmonary emphysema
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomohide Tamura
Organization	National Cancer Center Hospital
Division name	Division of Thoracic Oncology
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Email	JCOG_sir@ml.jcog.jp

Public contact
Name of contact person	1st name Middle name Last name Ikuo Sekine
Organization	JCOG1011 Coordinating Office
Division name	Division of Thoracic Oncology, National Cancer Center Hospital
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

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	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） 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） 順天堂大学医学部附属順天堂医院（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	2011 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/28625642
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	Completed
Date of protocol fixation	2011 Year 03 Month 02 Day
Date of IRB	2011 Year 03 Month 18 Day
Anticipated trial start date	2011 Year 03 Month 30 Day
Last follow-up date	2017 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	2011 Year 03 Month 30 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006306