UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010298
Receipt No. R000011812
Scientific Title A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma (JCOG1205/1206, HGNEC-EP/IP-P3)
Date of disclosure of the study information 2013/03/25
Last modified on 2021/01/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin
for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma
(JCOG1205/1206, HGNEC-EP/IP-P3)
Acronym A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin
for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma
(JCOG1205/1206, HGNEC-EP/IP-P3)
Scientific Title A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin
for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma
(JCOG1205/1206, HGNEC-EP/IP-P3)
Scientific Title:Acronym A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin
for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma
(JCOG1205/1206, HGNEC-EP/IP-P3)
Region
Japan

Condition
Condition Pathological stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the superiority of IP (irinotecan/cisplatin) over EP (etoposide/cisplatin) for pathological stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma (small cell carcinoma or large cell neuroendocrine carcinoma).
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 Relapse-free survival, Proportion of treatment completion, Adverse events, Serious adverse events, Second malignancy

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: 4 cycles of adjuvant chemotherapy with etoposide (100 mg/m2/day, day 1-3) and cisplatin (80 mg/m2/day, day 1) repeated every 3 weeks
Interventions/Control_2 B: 4 cycles of adjuvant chemotherapy with irinotecan (60 mg/m2/day, day 1, 8, 15) and cisplatin (60 mg/m2/day, day 1) repeated every 4 weeks
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Pathologically proven high-grade neuroendocrine carcinoma (small cell carcinoma including combined small cell carcinoma or large cell neuroendocrine carcinoma including combined large cell neuroendocrine carcinoma)
2) Pathological stage I-IIIA based on the TNM classification 2009
3) Pathologically proven either of R0, R1 (is), or R1 (cy+)
4) Aged 20 to 74 years old
5) ECOG performance status of 0 or 1
6) Lobectomy or more extended surgery was performed
7) ND 2a-1 or more extended lymph node dissection was performed.
8) Within 28 to 56 days after surgery
9) No distant metastases including brain metastasis
10) No prior chemotherapy or radiotherapy for any other cancers
11) Adequate organ functions
12) Diarrhea and intestinal obstruction of grade 1 or less based on CTCAE v4.0.
13) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychiatric disease
6) Serious postoperative complications
7) Patients requiring systemic steroids medication
8) Poorly controlled diabetes mellitus or routine administration of insulin
9) Poorly controlled hypertension
10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
11) Positive HBs antigen
12) Positive HIV antibody
13) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuboi Masahiro
Organization National Cancer Center Hospital East
Division name Division of Thoracic Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Email mtsuboi@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenmotsu Hirotsugu
Organization JCOG1205/1206 Coordinating Office
Division name Division of Thoracic Oncology, Shizuoka Cancer Center
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL (+81)055-989-5222
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
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)
北海道大学病院(北海道)
国立病院機構仙台医療センター(宮城県)
東北大学病院(宮城県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
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)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
日本医科大学付属病院(東京都)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
慶應義塾大学病院(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)
帝京大学医学部(東京都)
聖マリアンナ医科大学(神奈川県)
横浜市立市民病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
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)
北里大学医学部(神奈川県)
新潟大学医歯学総合病院(新潟県)
新潟県立がんセンター新潟病院(新潟県)
金沢大学医学部(石川県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
名古屋大学医学部(愛知県)
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)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
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)
関西医科大学附属枚方病院(大阪府)
兵庫県立がんセンター(兵庫県)
先端医療センター(兵庫県)
和歌山県立医科大学(和歌山県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
国立病院機構呉医療センター・中国がんセンター(広島県)
広島大学病院(広島県)
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)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
熊本中央病院(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 25 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
2013 Year 02 Month 01 Day
Date of IRB
2013 Year 02 Month 28 Day
Anticipated trial start date
2013 Year 03 Month 25 Day
Last follow-up date
2024 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 22 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.