UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017668 |
|---|---|
| Receipt number | R000020474 |
| Scientific Title | A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2019/11/27 15:50:55 |
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Basic information
Public title
A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Acronym
A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Scientific Title
A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Scientific Title:Acronym
A pilot study of definitive chemoradiotherapy using involved-field intensity-modulatd radiation therapy for patients with clinical stage IB-IIIC (non T4) esophageal carcinoma
Region
| Japan |
Condition
Condition
Esophageal neoplasm
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of definitive chemoradiotherapy using involved-field intensity-modulated radiation therapy for clinical stage IB-IIIC (non T4) esophageal carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate
Key secondary outcomes
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
Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day 1-4, day 29-32), cisplatin (75 mg/m2, day 1, 29) and involved-field intensity-modulated radiation therapy (50.4 Gy/28 fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m2, day 1-4) plus cisplatin (75 mg/m2, day 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma in thoracic esophagus
2)Patients refuse to receive or are unfit for a surgical resection
3) Clinical stage IB-IIIC except for cT4 (TNM 7th)
4) Aged 20 to 80 years old
5) ECOG Performance status 0 or 1
6) Adequate organ functions
7) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) Fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychosis
6) Patients requiring systemic steroids medication
7) Serum HBs antigen positive within 1 year
8) Poorly controlled diabetes mellitus
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
10) Interstitial pneumonia, fibroid lung, or severe emphysema
11) History of cerebrovascular disorder within 6 months
12) Connective tissue disease
13) History of a surgical resection for esophagus
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hiraoka |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3762
hiraok@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Sakanaka |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Radiation Oncology and Image-Applied Therapy
Zip code
6068371
Address
Sakyo-ku,
TEL
075-751-3762
Homepage URL
sakanaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
(tel)075-753-4680
ethcom@kuhp.kyoto-u.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 | 07 | Month | 23 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 23 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020474
