UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010570 |
|---|---|
| Receipt number | R000012363 |
| Scientific Title | Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed. |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2019/08/12 20:59:02 |
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Basic information
Public title
Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.
Acronym
Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.
Scientific Title
Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.
Scientific Title:Acronym
Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer, Malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of vitamin supplementation for chemotherapy with pemetrexed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The incidence of grade 3/4/5 non-hematologic toxicities
Key secondary outcomes
Other toxicities, Response rate, Progression-free survival
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 or malignant pleural mesothelioma
2. Planned to undergo pemetrexed-based therapy
3. PS (ECOG) 0-2
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. Allergy to treatment drugs
5. Pregnant or breast-feeding
6. Unable to take drugs orally
7. Other conditions inadequate for this research
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Hosomi |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology & Respiratory Medicine
Zip code
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
yhosomi@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kageaki Watanabe |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology & Respiratory Medicine
Zip code
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
kageakiwatanabe@cick.jp
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
| 2013 | Year | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012363
