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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020204
Receipt No. R000022996
Scientific Title Phase II trial of perioperative chemotherapy for esophageal cancer
Date of disclosure of the study information 2015/12/15
Last modified on 2016/12/15

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Basic information
Public title Phase II trial of perioperative chemotherapy for esophageal cancer
Acronym Phase II trial of perioperative chemotherapy for esophageal cancer
Scientific Title Phase II trial of perioperative chemotherapy for esophageal cancer
Scientific Title:Acronym Phase II trial of perioperative chemotherapy for esophageal cancer
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety, Efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Three-year relapse free survival
Key secondary outcomes Overall survival, time to treatment free survival, treatment completion rate, incidence of adverse events, incidence of treatment related death

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 S-1 80mg/m2/day is administered orally between day 1 and day 28. It takes 42 days for the one course. S-1 administration for 4 couses.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage IB-III(without T4 disease)
4) Aged 20 to 75 years old
5) ECOG PS of 0 or1
6) Performed neoadjuvant chemotherapy (5-FU+cisplatin)
7) No previous treatment of esophageal cancer except EMR or ESD
8) Adequate organ functions
9) Resectable disease (R0)
10) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Positive HBs antigen, or positive HCV antibody.
4) Pregnancy, possible pregnancy or breastfeeding.
5) Psychiatric disease.
6) Patients who need flucitosine, fenitoin or warfarin.
7) Poorly controlled diabetes mellitus
8) Severe pulmonary fibrosis or emphysema.
9) Serious angina or myocaedial infarcion within 3 months
10) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto university
Division name Department of Therapeutic Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3111
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoo Nomura
Organization Kyoto university
Division name Department of Therapeutic Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3518
Homepage URL
Email mnomura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical research support company with limited liability
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 愛知県がんセンター中央病院、岩手医科大学、大分大学、大阪医科大学、鹿児島大学、神奈川県立病院機構神奈川県立がんセンター、がん研究会有明病院、京都大学、熊本大学、慶応義塾大学、高知医療センター、国立がん研究センター東病院、国立病院機構大阪医療センター、国立病院機構九州がんセンター、国立病院機構四国がんセンター、静岡県立静岡がんセンター、千葉大学、東海大学、東京医科歯科大学、東北大学、名古屋大学、新潟大学医歯学総合病院、兵庫県立がんセンター、広島市立安佐市民病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 15 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022996

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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