UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034668 |
|---|---|
| Receipt number | R000039522 |
| Scientific Title | A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2024/10/31 10:18:07 |
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Basic information
Public title
A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Acronym
IMRT for esophageal cancer with stage I
Scientific Title
A phase II study of IMRT with concurrent chemotherapy for esophageal cancer with stage I
Scientific Title:Acronym
IMRT for esophageal cancer with stage I
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate efficacy and safety of IMRT with concurrent chemotherapy (CDDP+5-FU) for stage I esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-y progression-free survival rate
Key secondary outcomes
Grade 2 or more adverse events and 3-y overall survival rate
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
| Other |
Interventions/Control_1
IMRT without elective nodal irradiation
60Gy/30fractions
concurrent chemotherapy
5-FU 700mg/m2/day div(24h) day1-4,day29-32
CDDP 70mg/m2/day div(2h) day1,day29
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 thoracic esophageal squamous cell carcinoma
2.T1a or T1b with ultrasound endoscopy
3.no lymph node metastases by CT and FDG-PET
4.aged between 20-y and 79-y
5.Performance Status (ECOG):0-2
6.no severe complication
7.no indication or refusal for EMR/ESD or 8.written informed consent
Key exclusion criteria
1.past EMR/ESD history for primary site
2.patient with intramural metastasis
3.past irradiation history for thoracic
4.patient with active malignant tumor
5.patient with severe complication
6.patient with active infection
7.patient with severe interstitial pneumonia
8.patient with ECD or pace maker
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Jingu |
Organization
Tohoku Univeristy Hospital
Division name
Department of Radiuation Oncology
Zip code
980-0871
Address
1-1 Seiryou-chou, Aobaku
TEL
0227177312
kjingurad@yahoo.co.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
0227177312
Homepage URL
kjingurad@yahoo.co.jp
Sponsor or person
Institute
Tohoku Univeristy Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku Univeristy Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miyagi Prefecture Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.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
東北大学病院（宮城県）、宮城県立がんセンター（宮城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2018 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039522
