UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001846 |
|---|---|
| Receipt number | 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 09:27:37 |
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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
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
kenkato@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002214
