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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010057
Receipt No. R000011711
Scientific Title Phase II study of taxan for refractory esophageal cancer "KTT01"
Date of disclosure of the study information 2013/02/17
Last modified on 2018/10/23

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Basic information
Public title Phase II study of taxan for refractory esophageal cancer "KTT01"
Acronym KTT01
Scientific Title Phase II study of taxan for refractory esophageal cancer "KTT01"
Scientific Title:Acronym KTT01
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Anti tumor effect (overall survival) and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes response rate, disease control rate, progression free survival, toxicity, QOL

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 Weekly paclitaxel for docetaxel-resistant case.
Docetaxel for paclitaxel-resistant case.
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)Histological proven esophageal cancer (excluding small cell carcinoma and neuroendocrine carcinoma)
2) Measurable lesions not required
3) Following previous treatment
Intolerant or refractory to 5FU and cisplatin.
Refractory to paclitaxel or docetaxel.
4) Age>20 or older
5) ECOG performance status 0-2
6) Adequate interval from previous treatments
7) Adequate organ function
8) Expected >8 weeks survival
9) Written informed consent from patient
Key exclusion criteria Symptomatic brain metastasis
Paralytic or mechanical bowel obstruction
Confirmed or suspected infection
Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous)
Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure)
Pregnant or possibly pregnant, and nursing women
Sever neurologic disease
Other conditions not suitable for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ura Takashi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL 052-762-6111
Email tura@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ura Takashi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL 052-762-6111
Homepage URL
Email tura@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center 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 02 Month 17 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 01 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 07 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
2013 Year 02 Month 17 Day
Last modified on
2018 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011711

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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