UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004349 |
|---|---|
| Receipt number | 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 12:22:04 |
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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
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
h-mastu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Digestive surgery,
Kawasaki Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004710
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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