UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018360 |
|---|---|
| Receipt number | R000021257 |
| Scientific Title | radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study- |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2017/04/07 18:31:11 |
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Basic information
Public title
radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study-
Acronym
chemoradiotherapy for postoperative locoregional recurrent esophageal cancer
Scientific Title
radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional recurrent esophageal cancer -phase II study-
Scientific Title:Acronym
chemoradiotherapy for postoperative locoregional recurrent esophageal cancer
Region
| Japan |
Condition
Condition
postoperative locoregional (excluding hematogenous metastasis) recurrent esophageal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effectiveness and safety of radiotherapy combined with nedaplatin and 5-FU for postoperative locoregional (excluding hematogenous metastasis) recurrent esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival rate
Key secondary outcomes
tumor response, relapse-free survival rate, irradiated-field control rate and toxicity
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 | Other |
Interventions/Control_1
chemoradiotherapy
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
2) no other active cancer,
3) no serious cardiac, liver, or pulmonary disease,
4) creatinine clearance of more than 50 ml/min,
5) adequate bone marrow function (leukocyte count of 4000/ul, platelet count of 100,000/ul,
6) locoregional recurrence (including para-aortic lymph node metastasis) without distant metastasis after no residual tumor (R0) resection; extended radical esophagectomy with three-field (neck, mediastinum, and abdomen) lymph node dissection,
and 7) no previous therapy other than R0 resection.
Key exclusion criteria
see above
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Jingu |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Radiuation Oncology
Zip code
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 | |
| Middle name | |
| Last name | see above |
Organization
see above
Division name
see above
Zip code
Address
see above
TEL
-81-22-717-7312
Homepage URL
kjingu-jr@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Radiuation Oncology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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 | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23171077
Number of participants that the trial has enrolled
Results
The 5-year overall survival rate was 27.0% with a median survival period of 21.0 months.
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
| 2000 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2000 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2017 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021257
