UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006546 |
|---|---|
| Receipt number | R000007756 |
| Scientific Title | Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy. |
| Date of disclosure of the study information | 2011/10/14 |
| Last modified on | 2014/11/10 18:04:56 |
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Basic information
Public title
Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.
Acronym
Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.
Scientific Title
Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.
Scientific Title:Acronym
Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.
Region
| Japan |
Condition
Condition
Non small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of vitamin supplementation for cisplatin plus pemetrexed therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 3/4/5 neutropenia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vitamin B12 1000 ug, intramuscular,
Folate 350 - 500 ug, oral
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven non-squamous non-small cell lung cancer
2. Planned to undergo CDDP+PEM therapy
3. PS (ECOG) 0-1
4. Sufficient interval from prior treatment
5. Adequate key organ function
6. Life expectancy of at least 12 weeks
7. Written informed consent
Key exclusion criteria
1. Extensive interstitial pneumonitis
2. Severe complications
3. Active infection
4. History of cytotoxic chemotherapy
5. Active coexistent cancer
6. Need for continuous and systemic administration of corticosteroids
7. Need for continuous and systemic administration of vitamin B12
8. Symptomatic brain metastases
9. Massive pleural effusion or ascites
10. History of irradiation to more than half of pelvic bone
11. Allergy to treatment drugs
12. Pregnant or breast-feeding
13. Unable to take drugs orally
14. Other conditions inadequate for this research
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Shibuya |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
18-22, Honkomagome 3-chome, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Takagi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
18-22, Honkomagome 3-chome, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://theoncologist.alphamedpress.org/content/19/11/1194.abstract
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2014 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
