UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003180 |
|---|---|
| Receipt number | R000003857 |
| Scientific Title | Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2010/02/15 |
| Last modified on | 2018/03/01 18:32:13 |
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Basic information
Public title
Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer
Acronym
Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy
Scientific Title
Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Phase II study of oral vitamin B12 (cobalamin) supplementation with 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 safety of oral vitamin B12 supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of grade 3/4/5 neutropenia
Key secondary outcomes
The incidence of grade 3/4/5 toxicities and plasma homocysteine levels
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
Patients receive vitamin B12 (2mg for 7days, then 0.5mg) orally daily beginning 1 week before first dose of pemetrexed and throughout the study.
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 or cytologically proven non-squamous non-small cell lung cancer
2) Stage IIIorIV disease or postoperative recurrence
3) Experience of at least 1 regimen of cytotoxic chemotherapy
4) No experience of pemetrexed therapy
5) ECOG performance status 0-2
6) Interval of at least 3 weeks from last treatment
7) Adequate bone marrow, renal, hepatic and cardiopulmonary function
8) Life expectancy of at least 12 weeks
9) Written informed consent
Key exclusion criteria
1) Extensive interstitial pneumonitis
2) Severe complications
3) Active infection
4) Active double cancer
5) Need for continuous administration of systemic corticosteroids
6) Need for continuous administration of systemic vitamin B12
7) Symptomatic brain metastases
8) Massive pleural effusion or ascites
9) History of irradiation to pelvic bone
10) Allergy to treatment drugs
11) Pregnant or breast-feeding
12) Grade 3/4 peripheral sensory neuropathy
13) Unable to take drugs orally
14) History of gastric or small intestinal resection
15) Other conditions inadequate for this research
Target sample size
25
Research contact person
Name of lead principal investigator
| 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 3cho-me, 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 3cho-me, 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
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
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
| 2010 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00280-015-2954-x
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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2010 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003857
