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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016364
Receipt No. R000019003
Scientific Title Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Date of disclosure of the study information 2015/02/01
Last modified on 2020/02/01

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Basic information
Public title Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Acronym Phase I/II trial of chemotherapy with modified DCS
Scientific Title Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Scientific Title:Acronym Phase I/II trial of chemotherapy with modified DCS
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This phase I/II study is being conducted to determine the safety and the efficacy of chemotherapy using docetaxel, cisplatin and S-1 (DCS) for unresectable advanced esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Safety (Toxicities as assessed by NCI CTCAE ver. 4)
Phase II: Clinical response of chemotherapy(Feasibility as evaluated by RECIST ver 1.1)
Key secondary outcomes Phase II: Toxicities as assessed by NCI CTCAE ver. 4
Time to progression
Median survival time

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 Chemotherapy using Docetaxel+Cisplatin+S-1
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients with locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan.
(2)ECOG perfprmance status 0-1.
(3)Tissue from tumor must be available. Patients must have measurable disease.
(4)Patients may have received prior chemotherapy or radiotherapy; this must have beed completed at least 4 weeks. Patients may have received prior surgery or ESD; this must have beed completed at least 3 weeks. Patients may have received prior immunotherapy; this must have beed completed at least 1 week.
(5)Life expectancy > 3 months.
(6)Laboratory values as follows.
2000/mm3 < WBC < 12000/mm3
granulocyte count > 1500/mm3
hemoglobin > 8.0 g/dl
Platelet count > 100000/mm3
AST ALT < 150 IU/L
T-bil < 1.5 mg/dl
Creatinine < 1.5
Key exclusion criteria (1)Pregnency.
(2)Active or uncontrolled infection.
(3)Patients with a history of myocardial infarction within the previous 3 months.
(4)Patients with uncontrolled diabetes melitus or hypertension.
(5)Patients with clinically apparent central nervous system metastases
(6)Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshiyasu
Middle name
Last name Ojima
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama, Japan
TEL 073-441-0613
Email tojima@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Toshiyasu
Middle name
Last name Ojima
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama, Japan
TEL 073-441-0613
Homepage URL
Email tojima@wakayama-med.ac.jp

Sponsor
Institute Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization Second Department of Surgery, Wakayama Medical University
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 Second Department of Surgery, Wakayama Medical University
Address Kimiidera 811-1
Tel 0734410613
Email tojima@wakayama-med.ac.jp

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
2015 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
2014 Year 05 Month 27 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 28 Day
Last modified on
2020 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019003

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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