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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004349
Receipt No. R000004710
Scientific Title PhaseI/II study of Docetaxel/S-1 with radiation for unresectable and/or recurrent esophageal cancer
Date of disclosure of the study information 2010/11/01
Last modified on 2013/10/23

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Basic information
Public title PhaseI/II study of Docetaxel/S-1 with radiation for unresectable and/or recurrent esophageal cancer
Acronym SP vs DS
Scientific Title PhaseI/II study of Docetaxel/S-1 with radiation for unresectable and/or recurrent esophageal cancer
Scientific Title:Acronym SP vs DS
Region
Japan

Condition
Condition unresectyable esophageal cancer,
recurrent esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and the safety of this regimen for unresectable esophageal cancer patient without distant metastasis and recurrent esophageal cancer patient, using the dosage determined by previous phase I study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes overall response
Key secondary outcomes Overall suevivalsurvival
Time to progression
toxicity
Local conterol rate

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 given S-1 (60mg/m2/day) orally from days 1 to 14, and Docetaxel (20 mg/m2 ) intravenously on days 1 and 8. Patients received radiation in 2.0 Gy daily fractions from days 1 to 21, for a total of 30 Gy. Patients were given a seven-day rest after the first course, and then treated with the same regimen from days 28 to 49.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.The patients must have histologically proven squamous cell carcinoma of the esophagus.
2.The tumor is T4 and/or M1 LYM without other organ metastasis or recurrent cancer.
3.The tumor has a measurable lesion for evaluation.
4.No previous treatment or more 4 weeks passed before previous treatment
5.All areas of the disease can be encompassed in the radiation port.
6.The patient's performance status is 0 to 1.
7.The patient's age is 18- 80 years.
8. Adequate organ function
9.WBC count is 4,000/mm3 or more and neutrophil count is 2000 /mm3 or more
Platelet count is 100,000/mm3 or more
Hemoglobin is 9.5 g/dl or more
AST and ALT levels are within twice the normal upper limits
Serum bilirubin level is 1.5 mg/dl or less
Serum creatinin levels are 1.5 mg/dl or less
10.Life expectancy expectd more than 12 weeks
11. Written informed consent
Key exclusion criteria Excluded criteria is follow;
1.the case complicated severe heart failure,liver chirrhosis, uncontrolled diabets, interstitial pneumonia or fibriod lung, pooling of pleural effusion needed treatment and pericardial effusion.
2.the case suspected of infection with feaveer
3.the case had the motion disturbance, peripheral nerve palsy and severe edema
4.the case complicated other active cancer
5.pregnant woman or lactational woman
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiro Hirai
Organization Kawasaki Medical University
Division name Department of Digestive Surgery
Zip code
Address Matsushima 577, Kurashi City, Okayama
TEL 086-462-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Matsumoto
Organization Kawasaki Medical University
Division name Department of Digestive Surgery
Zip code
Address Matsushima 577, Kurashi City, Okayama
TEL 086-462-1111
Homepage URL
Email h-mastu@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Digestive surgery,
Kawasaki Medical University
Institute
Department

Funding Source
Organization not existed
Organization
Division
Category of Funding Organization Self funding
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 川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2006 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 07 Day
Last modified on
2013 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=R000004710

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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