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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010549
Receipt No. R000012334
Scientific Title Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Date of disclosure of the study information 2013/04/20
Last modified on 2017/10/26

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Basic information
Public title Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Acronym Second line treatment of Temozolomide in neuroendocrine carcinoma
Scientific Title Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Scientific Title:Acronym Second line treatment of Temozolomide in neuroendocrine carcinoma
Region
Japan

Condition
Condition Neuroendocrine carcinoma (Grade3)
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Endocrine surgery
Breast surgery Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The pourpose of this study is to evaluate the efficacy of Temozolomide monotheraphy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall response rate
Key secondary outcomes overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients were treated temozolomide (150mg/m2) orally on day1 to 5 of 28-day cycle.
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
18 years-old <=
Age-upper limit
76 years-old >
Gender Male and Female
Key inclusion criteria pathological diagnosed neuroendocrine carcinoma Grade3
Any primary sites are included
The cases of refractory first-line treatment
ECOG PS 0-1
granulocyte count > 1500
platelet count > 10000
Key exclusion criteria cerebral vascular disease
untreatment bone fracture
uncontrolable ulcer
tendency of bleeding
another major carcinoma
cerebral vascular disease
active infection
HBV hepatitis or carrier
uncontrolable hypertension
intestinal pneumonia
past history of intake aboutimmunosuppressive agents
tubeluclosis
cardiac disease
pregnancy
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kobayashi Noritoshi
Organization Yokohama City University Hospital
Division name Clinical Oncology
Zip code
Address 3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL 045-787-2623
Email norikoba@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kobayashi Noritoshi
Organization Yokohama City University Hospital
Division name Clinical Oncology
Zip code
Address 3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL 045-787-2623
Homepage URL
Email norikoba@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Other
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
2013 Year 04 Month 20 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 20 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 20 Day
Last follow-up date
2017 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information primary end point
overall response

secondary end point
time to treatment failure
progression-free survival
overall survival

adverse events

Management information
Registered date
2013 Year 04 Month 19 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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