UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer
Title of the study (Brief title)	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	Yusuke Takagi
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology
Address	18-22, Honkomagome 3cho-me, Bunkyo- ku, Tokyo
TEL
Email

Public contact
Name of contact person	Yusuke Takagi
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology
Address	18-22, Honkomagome 3cho-me, Bunkyo- ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs00280-015-2954-x
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003857