UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019269 |
|---|---|
| Receipt number | R000022281 |
| Scientific Title | a phase II study of chemoradiotherapy with CDDP+5-FU+DOC for postoperaitve loco-regional recurrent esophageal cancer |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2025/04/14 11:48:41 |
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Basic information
Public title
a phase II study of chemoradiotherapy with CDDP+5-FU+DOC for postoperaitve loco-regional recurrent esophageal cancer
Acronym
a phase II study of chemoradiotherapy with CDDP+5-FU+DOC for postoperaitve loco-regional recurrent esophageal cancer
Scientific Title
a phase II study of chemoradiotherapy with CDDP+5-FU+DOC for postoperaitve loco-regional recurrent esophageal cancer
Scientific Title:Acronym
a phase II study of chemoradiotherapy with CDDP+5-FU+DOC for postoperaitve loco-regional recurrent esophageal cancer
Region
| Japan |
Condition
Condition
postoperative loco-regional recurrent esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy and safety of radiotherapy combined with CDDP+5-FU+DOC for postoperative loco-regional recurrent esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression-free survival, toxicity
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 | Maneuver |
Interventions/Control_1
radiotherapy: 60Gy/30fx/6weeks (local field)
CDDP: 40mg/m2 day1, 15, 29
DOC: 35mg/m2 day1, 15, 29
5-FU: 1000mg/m2 day1-5, 15-19, 29-33
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) performed esophagectomy and D2/3 dissection (R0 resectio)
2) loco-regional recurrence with CT and/or PET-CT
3) ECOG PS=0-2
4) age; 20-75
5) no severe complication
6) written informed consent
Key exclusion criteria
1) with distant organ metastasis
2) with irradaiation history
3) recurrence after EMR
4) second primary
5) double active cancer
6) with severe complication
7) pregant female
8) active infection
9) regular use steroid
10) with pace maker or implantable cardioverter defibrillator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku university graduate school of Medicine
Division name
Department of Radiuation Oncology
Zip code
9808574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
kjingu-jr@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku university graduate school of Medicine
Division name
Department of Radiuation Oncology
Zip code
9808574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
+81-22-717-7312
Homepage URL
kjingu-jr@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku university graduate school of Medicine
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
IRB of Tohoku Univeristy Hospital
Address
1-1 Seiryou-chou, Aobaku, Sendai
Tel
022-728-4105
med-kenkyo@grp.tohoku.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 | 10 | Month | 07 | 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
28
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
I will publish it after a presentation in international cofference.
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022281
