UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001869 |
|---|---|
| Receipt number | R000002252 |
| Scientific Title | A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2019/04/18 10:19:00 |
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Basic information
Public title
A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation
Acronym
Amaterasu 4
Scientific Title
A randomized, double blind, comparative study of STATUS D3 (vitamin D3) versus placebo in patients with lung cancer to prevent relapse after operation
Scientific Title:Acronym
Amaterasu 4
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will determine if vitamin D3 peroral administration of 1200IU/day for 1 year can prevent relapse of lung cancer after operation, by conducting a double blind randomized controlled clinical trial and by stratification with vitamin D receptor SNPs as well as with pathological stages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
vitamin D3 suppliment
Interventions/Control_2
placebo
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. First operation for lung cancer at Jikei University hospitals
2. Obtained informed consent
3. Age 20 and more and less than 75 years old
Key exclusion criteria
1. Already taking vitamin D supplement or 1,25 vitamin D
2. History of kidney stone
3. Other difficulties judged by the surgeon in charge
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
Jikei University School of Medicine
Division name
Division of Molecular Epidemiology
Zip code
Address
3-25-8 Nishi-shimbashi Minato-ku, Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emi Suzuki |
Organization
Jikei University School of Medicine
Division name
Division of Molecular Epidemiology
Zip code
Address
TEL
Homepage URL
emisuzu@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30018118
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30018118
Number of participants that the trial has enrolled
155
Results
The 5-year RFS of the vitamin D and placebo groups was 65% and 57%, respectively (HR, 1.15; 95%CI, 0.64 to 2.05; P=0.64). The 5-year OS of the vitamin D and placebo groups was 76% and 78%, respectively (HR, 1.22; 95%CI, 0.54 to 2.79; P=0.63).
Results date posted
| 2019 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 68 years, and three-quarters of the patients were men. Early stages from IA to IIB and adenocarcinoma accounted for 90% and 81% of the study population, respectively.
Participant flow
A total of 155 patients with NSCLC were randomly assigned to receive vitamin D supplements (n=77) or placebo (n=78) in a double-blind setting. 72 patients in the vitamin D group and 72 patients in the placebo group were analyzed.
Adverse events
There were no more cases of urinary stones, hypercalcemia, and serious adverse events in the vitamin D group than in the placebo group.
Outcome measures
The primary and secondary outcomes were RFS and OS, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2009 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002252
| Research Plan | |
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| Registered date | File name |
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