UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026403 |
|---|---|
| Receipt number | R000030112 |
| Scientific Title | Clinical Implication of VMAT for Chemoradiation in CePh-Type Cervical Esophageal Cancer and Hypopharyngeal Cancer Extending to the Cervical Esophagus |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2018/03/31 11:15:13 |
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Basic information
Public title
Clinical Implication of VMAT for Chemoradiation in CePh-Type Cervical Esophageal Cancer and Hypopharyngeal Cancer Extending to the Cervical Esophagus
Acronym
Cohort study of VMAT for CePh-Type Cervical Esophageal Cancer and Hypopharyngeal Cancer Extending to the Cervical Esophagus
Scientific Title
Clinical Implication of VMAT for Chemoradiation in CePh-Type Cervical Esophageal Cancer and Hypopharyngeal Cancer Extending to the Cervical Esophagus
Scientific Title:Acronym
Cohort study of VMAT for CePh-Type Cervical Esophageal Cancer and Hypopharyngeal Cancer Extending to the Cervical Esophagus
Region
| Japan |
Condition
Condition
CePh-type cervical esophageal carcinoma and hypopharyngeal cancer with esophageal invasion
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
CePh-Type cervical esophageal cancer (ce-phCEC) and hypopharyngeal cancer extending to the Ce (HPCce) may be similarly dealt in RT technique because of nodal commonplace. We started a cohort study using VMAT in concurrent chemoradiotherapy (CCRT) for patients with ce-phCEC and HPCe to establish more appropriate RT dose and delineation for PTV and OAR. Objectives of this study is to present that VMAT is a beneficial technique of irradiation for the upper thoracic area connected to the lower neck to get a better result than before.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Three year OSs are presented in following groups, respectively: 1.the cohort group; CePh-type cervical esophageal cancer, 2.the cohort group; hypopharyngeal cancer with esophageal invasion, 3.the control group; CePh-type cervical esophageal cancer, and 4.the control group; hypopharyngeal cancer with esophageal invasion
Key secondary outcomes
In the cohort group and the control group, 3-year recurrent free survival (RFS), occurrence rates of acute and late toxicities are presented, respectively ('Acute' means within 3 months after CCRT beginning). All toxicities are referred by CTCAE ver.4.0.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
| Not applicable |
Age-upper limit
| 83 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of CePh-type esophageal cancer and hypopharyngeal cancer with esophageal invasion to be treated with definitive concurrent chemoradiation (CCRT), without any RT history in the head and neck and thorax. Before initial intent dose is administered, if patients was changed from CCRT to induction CRT(RT dose is less than or = 50Gy ) followed by salvage surgery, they are selected by initial intent.
Key exclusion criteria
Patients diagnosed as M1 or M1lym, patients whose primary subsite of cervical esophageal cancer is CeUt with more than 1cm Ut invasion, patients whose primary subsite of hypopharyngeal cancer is pyriform sinus because of a slight difference of nodal area between defined the patients for this protocol.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyako MYOJIN |
Organization
Social care corporation Keiyukai sapporo Hospital
Division name
Department of Radiation oncolgy
Zip code
Address
Kita1-1,Hondori 14 cho-me,Shiroishi-ku,SAPPORO
TEL
011-863-2101
miyako@keiyukaisapporo.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuo HONGO |
Organization
Social care corporation Keiyukai sapporo Hospital
Division name
Administrative office
Zip code
Address
Kita1-1,Hondori 14 cho-me,Shiroishi-ku,SAPPORO
TEL
011-863-2101
Homepage URL
http://www.keiyukaisapporo.or.jp
nhongo@keiyukaisapporo.or.jp
Sponsor or person
Institute
Social care corporation Keiyukai sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
Social care corporation Keiyukai sapporo Hospital
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
| 2017 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 10 | Day |
Other
Other related information
This reperch is an observational study. One-arm cohort group is defined as following; patients constructed from CePh type esophageal cancer and hypopharyngeal cancer invasive to the esophagus, are prospectively treated with chemoradiation using hybrid VMAT 68-69Gy/33F/7wks.
When the results are published, additional information about historical results of the controls of CePh type esophageal cancer and hypopharyngeal cancer invasive to the esophagus are presented as comparison data.
Management information
Registered date
| 2017 | Year | 03 | Month | 05 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030112
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