UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of alternating chemoradiotherapy combined with proton beam therapy and intra-arterial infusion chemotherapy for advanced tongue cancer
Title of the study (Brief title)	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	Kanako Takayama
Organization	Southern Tohoku Proton Therapy Center
Division name	department of radiation oncology
Address	7-172, Yatsuyamada, Koriyama, Fukushima
TEL	024-934-3888
Email	tkana-tky@umin.ac.jp

Public contact
Name of contact person	Kanako Takayama
Organization	Southern Tohoku Proton Therapy Center
Division name	department of radiation oncology
Address	7-172, Yatsuyamada, Koriyama, Fukushima
TEL	024-934-3888
Homepage URL
Email	tkana-tky@umin.ac.jp

Sponsor
Institute	Department of radiation oncology, Southern Tohoku Proton Therapy Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007/s00432-015-2069-0
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037332