UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Temozolomide monotheraphy in patients with first line treatment-refractory neuroendocrine carcinoma
Title of the study (Brief title)	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	Kobayashi Noritoshi
Organization	Yokohama City University Hospital
Division name	Clinical Oncology
Address	3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL	045-787-2623
Email	norikoba@yokohama-cu.ac.jp

Public contact
Name of contact person	Kobayashi Noritoshi
Organization	Yokohama City University Hospital
Division name	Clinical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012334