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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013882
Receipt No. R000016196
Scientific Title A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401
Date of disclosure of the study information 2014/06/10
Last modified on 2019/05/07

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Basic information
Public title A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401
Acronym Randomized P2 ED SCLC maintenance CPT vs AMR
Scientific Title A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401
Scientific Title:Acronym Randomized P2 ED SCLC maintenance CPT vs AMR
Region
Japan

Condition
Condition chemotherapy-naive extensive disease small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of amrubicin versus irinotecan as maintenance therapy to be performed subsequent to initial chemotherapy with cisplatin and irinotecan for extensive disease small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival rate at 6 months
Key secondary outcomes progression free survival, overall survival,progression free survival of maintenance therapy, adverse events, 1 year survival rate, transition rate to maintenance therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive induction therapy of cisplatin plus irinotecan followed by irinotecan maintenance therapy (60mg/m2, day1,8, every 3 weeks).
Interventions/Control_2 Patients receive induction therapy of cisplatin plus irinotecan followed by amrubicin maintenance therapy (35mg/m2, day1-3, every 3 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) non-small-cell lung cancer
2) Chemotherapy-naive
3) Radiotherapy-naive
4) IIIB to IV or postoperative recurrent without indication of resection or radiation.
5) ECOG-PS 0 or 1 or 2
6) Measurable lesion by RECIST ver.1.1 criteria
7) Adequate organ function
8) Life expectancy more than 3 months
9) Written informed consent
Key exclusion criteria 1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan
2) History of heart disorder.
3) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes)
4) Regular use of corticosteroid (less than 2 weeks interval after cessation)
5) Pregnancy or lactation, or those who decline contraception
6) Contraindication with chemotherapy
7) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more
8) Those judged to be not suitable by the attending physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Morikawa
Organization Iwate Medical University School of Medicine
Division name Division of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine
Zip code
Address 19-1, Uchimaru, Morioka,Iwate, 020-8505, JAPAN
TEL +81-19-651-5111(2334)
Email carcinoma@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Tanaka
Organization Hirosaki University Graduate School of Medicine
Division name Cardiology, Respiratory medicine and Nephrology
Zip code
Address 5 Zaifu-cho Hirosaki city, Aomori Prefecture, JAPAN
TEL 0172-39-5057
Homepage URL
Email xyghx335@gmail.com

Sponsor
Institute North Japan Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Funding Source
Organization Iwate Medical University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 NJLCG1401
Org. issuing International ID_1 North Japan Lung Cancer Study Group
Study ID_2 HOT1401
Org. issuing International ID_2 Hokkaido Lung Cancer Clinical Study Group
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 10 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 Terminated
Date of protocol fixation
2014 Year 05 Month 02 Day
Date of IRB
2014 Year 07 Month 14 Day
Anticipated trial start date
2014 Year 07 Month 20 Day
Last follow-up date
2018 Year 07 Month 20 Day
Date of closure to data entry
2018 Year 10 Month 20 Day
Date trial data considered complete
2018 Year 10 Month 20 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/11/07 ED-SCLC HOT-NJ1401 割付.xls


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