UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024091
Receipt number R000027730
Scientific Title Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor
Date of disclosure of the study information 2016/09/17
Last modified on 2023/03/24 18:46:49

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Basic information

Public title

Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor

Acronym

CAPTEM therapy for unresectable neuroendocrine tumor

Scientific Title

Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor

Scientific Title:Acronym

CAPTEM therapy for unresectable neuroendocrine tumor

Region

Japan


Condition

Condition

gastroenteropancreatic neuroendocrine tumor

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of the CAPTEM therapy for the patients with unresectable gastroenteropancreatic neuroendocrine tumors

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall response rate

Key secondary outcomes

Time to treatment failure
Progression-free survival
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

Chemotherapy by Capecitabine and Temozolomide

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

76 years-old >

Gender

Male and Female

Key inclusion criteria

unresectable gastroenteropancreatic neuroeondocrine tumor (WHO 2010 Grade 1,2,3) and primary unknown NET

Key exclusion criteria

Hb < 8.0g/dl
WBC <3000
Neutrocyte <1500
Plt <100000
severe liver or renal disease
T-bil> 3ULN
Alb <3.0g/dl
AST> 5 X ULN
ALT> 5 X ULN
brain metastasis
severe bone metastasis
uncontrolable DM
severe heart disease

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Ichikawa

Organization

Yokohama City University Hospital

Division name

Department of Oncology

Zip code

236-0004

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 Noritoshi
Middle name
Last name Kobayashi

Organization

Yokohama City University Hospital

Division name

Department of Oncology

Zip code

236-0004

Address

3-9, Fuku-ura, Kanazawa-ku, Yokohama

TEL

045-787-2623

Homepage URL


Email

norikoba@yokohama-cu.ac.jp


Sponsor or person

Institute

yokohama city university hospital oncology division

Institute

Department

Personal name



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

Yokohama City University Hospital

Address

3-9, Fuku-ura, Kanazawa-ku, Yokohama

Tel

+81457872623

Email

norikoba@yokohama-cu.ac.jp


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

2016 Year 09 Month 17 Day


Related information

URL releasing protocol

undisclosed

Publication of results

Unpublished


Result

URL related to results and publications

undisclosed

Number of participants that the trial has enrolled

35

Results

undisclosed

Results date posted

2022 Year 02 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

undisclosed

Participant flow

undisclosed

Adverse events

undisclosed

Outcome measures

undisclosed

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 09 Day

Date of IRB

2016 Year 10 Month 01 Day

Anticipated trial start date

2016 Year 09 Month 19 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 09 Month 17 Day

Last modified on

2023 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027730


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name