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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026403
Receipt No. 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

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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
Email 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
Email nhongo@keiyukaisapporo.or.jp

Sponsor
Institute Social care corporation Keiyukai sapporo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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