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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001846
Receipt No. R000002214
Scientific Title multicenter phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II, II esophageal cancer
Date of disclosure of the study information 2009/04/04
Last modified on 2009/04/03

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Basic information
Public title multicenter phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II, II esophageal cancer
Acronym Elderly cStageII, III(non T4) esophageal cancer: DTX-RT PhaseII
Scientific Title multicenter phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II, II esophageal cancer
Scientific Title:Acronym Elderly cStageII, III(non T4) esophageal cancer: DTX-RT PhaseII
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of chemoradiotheray with docetaxel
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-years survival
Key secondary outcomes Complete Response Rate,
Progression free survival,
Adverse Events,
Late Adverse Events

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 Chemoradiaion(Docetaxel+RT)
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
70 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria patients must fulfill all of the following criteria to be eligible for the trial
1 thoracic esophageal cancer
2 histologically confirmed squamous cell carcinoma or adenocarcinoma or adenosquamous carcinoma
3 clinical stage from II to III except T4
4 patient do not receive any previous therapy for esophageal cancer and previous chemotherapy for any other malignancy
5 age from 70 to 80 years
6 ps of 0 and 1
7 patient do not want to receive
esophagectomy
8 adequate organ funcion
9 no evidence to need treatment of ECG within 28 days prior to entering this study
10 written informed consent
Key exclusion criteria patients who fulfill any of the following criteria are not eligible for the study
1 esophageal fistula
2 severe comorbidity
3 active infection
4 history of previous radiotherapy to thorax
5 chest Xray shows obvious interstitial pneumonia and pulmonary fibrosis
6 history of any other malignancy which is including synchronal double cancer or
double cancer of disease free for less than 5 years
but they are not including the carcinoma in situ or intramucosal cancer diagnosed as cure by local procedure
7 motor paralysis or peripheral neuropathy or edema
8 active men and women unwilling to practice effective contraception
9 evidence of psychological disease and symptom that may affect patient compliance with the study
10 patient who is judged as an inappropriate case by the doctor in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Hokamura
Organization National Cancer Center Hospital
Division name Surgical Oncology
Zip code
Address 5 1 1 tsukiji chuoku tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name ken kato
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology
Zip code
Address 5 1 1 tsukiji chuoku tokyo japan
TEL 03-3542-2511
Homepage URL
Email kenkato@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 04 Month 04 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
Date of protocol fixation
2008 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 03 Day
Last modified on
2009 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002214

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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