UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014684 |
|---|---|
| Receipt number | R000017071 |
| Scientific Title | Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy) |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2023/02/02 18:48:09 |
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Basic information
Public title
Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy)
Acronym
Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy)
Scientific Title
Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy)
Scientific Title:Acronym
Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy)
Region
| Japan |
Condition
Condition
clinical stage IA esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of concurrent chemoradiotherapy with S-1 plus cisplatin for clinical stage IA (UICC-TNM ver.7.0) esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year overall survival
Key secondary outcomes
Overall survival, Progression free survival, Adverse event
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
endoscopic resection followed by concurrent chemoradiotherapy with S-1 plus cisplatin
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 cell carcinoma or basaloid carcinoma of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 80 years old
4) ECOG PS of 0, 1 or 2
5) Clinical stage IA (cT1a or cT1bN0M0) or pT1 which need therapy
6) No need for measurable lesion
7) No previous treatment of esophageal cancer
8) Adequate food intake
9) No palsy of recurrent nerve
10) Adequate organ functions
11) Refused esophagectomy
12) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Uncontrollable diabetes millutus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2 weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo)
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuou-ku, Osaka, Japan
TEL
+81669451181
yamamoto-sa@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuou-ku, Osaka, Japan
TEL
+81669451181
Homepage URL
yamamoto-sa@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
Ethics Review Board of Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaak, Japan, 541-8567
Tel
+81669451181
yamamoto-sa@mc.pref.osaka.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
| 2014 | Year | 07 | Month | 30 | 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
| 2014 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017071
