UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013882 |
|---|---|
| Receipt number | 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 11:35:38 |
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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)
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
xyghx335@gmail.com
Sponsor or person
Institute
North Japan Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
