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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name