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


Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name