UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032732 |
|---|---|
| Receipt number | R000037332 |
| Scientific Title | Study of alternating chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/05/27 20:59:44 |
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Basic information
Public title
Study of alternating chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer
Acronym
Chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer
Scientific Title
Study of alternating chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer
Scientific Title:Acronym
Chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer
Region
| Japan |
Condition
Condition
locally advenced tongue cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of alternating chemoradiotherapy followed by proton beam therapy combined with intra-arterial infusion chemotherapy for locally advanced tongue cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival rate
Key secondary outcomes
local control rate, locoregional control rate, progression free survival rate, 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 |
Interventions/Control_1
Treatment consisted of 2 courses of alternating chemoradiotherapy (radiotherapy:4 weeks) and intra-arterial infusion chemotherapy(cisplatin 20-40mg/m2) combined with 3 weeks of proton beam therapy
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Untreated tongue cancer
2)Histologically confirmed squamous cell carcinoma
3)Stage III-IV(UICC ver.7)
4)Performance status:0-2(ECOG)
5)18-70 years old
6)WBC:>3,000/mm2, Platelet count:>100,000/mm2, Hemoglobin:>9g/dl
7)No history of radiotherapy or surgery for the head and neck region
Key exclusion criteria
1)History of serious drug allegies
2)With severe complications(hepatic disorder, renal disorder, heart disorder, cerebral infraction)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanako Takayama |
Organization
Southern Tohoku Proton Therapy Center
Division name
department of radiation oncology
Zip code
Address
7-172, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-3888
tkana-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Takayama |
Organization
Southern Tohoku Proton Therapy Center
Division name
department of radiation oncology
Zip code
Address
7-172, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-3888
Homepage URL
tkana-tky@umin.ac.jp
Sponsor or person
Institute
Department of radiation oncology, Southern Tohoku Proton Therapy Center
Institute
Department
Personal name
Funding Source
Organization
Southern Tohoku General Hospital
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
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
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00432-015-2069-0
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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037332
