UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010298
Receipt number 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 2022/08/30 17:22:34

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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 or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



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

Main results already published

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB

2013 Year 03 Month 13 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

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.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