UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001977 |
|---|---|
| Receipt number | R000002412 |
| Scientific Title | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2019/04/05 12:13:08 |
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Basic information
Public title
A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation
Acronym
Amaterasu 5
Scientific Title
A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with cancer in gastrointestinal tract to prevent relapse after operation
Scientific Title:Acronym
Amaterasu 5
Region
| Japan |
Condition
Condition
cancers in gastrointestrinal tract
esophageal cancer, gastric cancer, colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. Targeting on cancers in gastrointestinal tract (esophageal cancer, gastric cancer and colon cancer), we examine relationship between relapse free survival and serum vitamin D concentration/single nuclear polymorphisms of vitamin D receptor
2. By peroral administration of either vitamin D3 (2,000IU) or placebo in double blind manner, vitamin D can prevent relapse and death after primary operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relapse free survival
overall survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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 supplement
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. First operation for cancer of gastrointestinal tract at International University of Health and Welfare hospital
2. Obtained informed consent
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
1
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 105-8461 Japan
TEL
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
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
Organization
Division
Category of Funding Organization
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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
417
Results
The 5-year RFS was 77% vs 69%; hazard ratio (HR) for relapse or death, 0.76; 95% CI, 0.50 -1.14; P = 0.18. The 5-year overall survival in the vitamin D and placebo groups was 82% vs. 81%; HR for death, 0.95; 95%CI, 0.57-1.57; P=0.83. In a subgroup of patients with serum 25(OH)D levels between 20 and 40 ng/mL at baseline, the 5-year RFS was 85% vs 71%; HR for relapse or death, 0.46; 95%CI, 0.24-0.86; P=0.02; Pinteraction=0.04.
Results date posted
| 2019 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 04 | Month | 10 | Day |
Baseline Characteristics
The AMATERASU Trial was a randomized, double-blind, placebo-controlled trial at a single university hospital in Japan. Enrollment began in January 2010 and follow-up was completed in February 2018. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Of 439 eligible patients, 15 declined and 7 patients were excluded after operation.
Participant flow
The patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/day, n=251) or placebo (n=166) from the first postoperative outpatient visit to until the end of the trial.
Adverse events
Fractures occurred in 3 (1.3%) of vitamin D group and 5 (3.4%) of placebo. Urinary stones were in 2 (0.9%) of vitamin D and 0 (0.0%) of placebo.
Outcome measures
The primary outcome was relapse-free survival (RFS) time to relapse or death.
The secondary outcome was overall survival time to death from any cause. Subgroups analyzed were baseline serum 25(OH)D level 0 to <20 ng/mL, 20 to 40 ng/mL, and >40 ng/mL; because of small sample size for highest level, interactions were tested only between the low and middle baseline levels.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2008 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002412
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/04/05 | Protocol + SAP (Original + final + Amandament).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/04/05 | 2019.3.22..data repository (1).xlsx |
