UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009011 |
|---|---|
| Receipt number | R000010505 |
| Scientific Title | JIVROSG-0808(RADPLAT Japan, maxillary carcinoma-II) Cisplatinum (CDDP) transarterial chemoradiptherapy for patients with maxillary carcinoma, pahse II study |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2022/10/11 08:38:24 |
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Basic information
Public title
JIVROSG-0808(RADPLAT Japan, maxillary carcinoma-II) Cisplatinum (CDDP) transarterial chemoradiptherapy for patients with maxillary carcinoma, pahse II study
Acronym
JIVROSG-0808 CDDP transarterial chemoradiptherapy for patients with maxillary carcinoma, pahse II study
Scientific Title
JIVROSG-0808(RADPLAT Japan, maxillary carcinoma-II) Cisplatinum (CDDP) transarterial chemoradiptherapy for patients with maxillary carcinoma, pahse II study
Scientific Title:Acronym
JIVROSG-0808 CDDP transarterial chemoradiptherapy for patients with maxillary carcinoma, pahse II study
Region
| Japan |
Condition
Condition
maxillary carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of transarterial chemo-infusion therapy with using cisplatinum (CDDP) combined with radiation therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local control rate
Key secondary outcomes
primary tumor response rate, frequency and grade of adverse event, 5 years survival rate and reurrence rate
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 | Maneuver |
Interventions/Control_1
Transarterial infusion of cisplatinum to feeding artery of maxillary carcinoma and irradiation to the same lesion.
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
Maxillaruy carcinoma which was pathologically diagnosed as squamous cell carcinoma.
Tumor stage is T3 or T4 based on UICC 7th edition.
Selective angiography of feeding artery is feasible.
Life expectancy is 8 weeks or more.
Performance status (ECOG) is 1, 2 or 3.
Function of major organs (e.g., cardiac function, renal function) are preserved.
Informed concent is obtained from the patient.
Key exclusion criteria
In status of myelosuppression.
Serious infectious lesion exists in head or neck region.
Serious complications exist(interstitial pneumonia, uncontrolable diabetes, heart failure, renal dysfunction, liver dysfunction, etc).
Viable double cancer or other malignant disease exists.
Patients who have past history of radiation therapy to head and neck region.
Patients who have allergic history for iodine contrast medium or platinums.
Patients who have serious mental disorder.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Arai |
Organization
National cancer center hospital
Division name
Department of Diagnostic radiology
Zip code
1040045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
0335422511
sugasuga_shun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norimitsu |
| Middle name | |
| Last name | Tanaka |
Organization
Kurume University
Division name
Department of Radiology
Zip code
8300011
Address
67, Asahimachi, Kurume City, Fukuoka
TEL
0942-31-7576
Homepage URL
nori@med.kurume-u.ac.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku
Tel
03-3542-2511
sugasuga_shun@yahoo.co.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
北海道大学病院放射線科（吉田大介）
岩手医科大学放射線科（中里龍彦）
総合南東北病院血管内治療センター（今井茂樹）
宮城県立がんセンター放射線科（松本恒）
国立がんセンター放射線診断部（荒井保明）
奈良県立医科大学放射線科（中川裕之）
産業医科大学放射線科（興梠征典）
久留米大学放射線科（田中法瑞）
兵庫医科大学放射線科（石蔵礼一）
聖マリアンナ医科大学（滝澤謙治）
山形大学放射線科（鹿戸将史）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
45
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
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010505
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