UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013706
Receipt number R000015800
Scientific Title Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)
Date of disclosure of the study information 2014/04/14
Last modified on 2017/05/16 19:33:36

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Basic information

Public title

Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Acronym

Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Scientific Title

Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Scientific Title:Acronym

Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC)

Region

Japan


Condition

Condition

locally advanced maxillary sinus cancer

Classification by specialty

Hematology and clinical oncology Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and the efficacy of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

3-year overall survival, The incidence of dose limiting toxicity

Key secondary outcomes

Overall survival, Event-free survival, Local event-free survival, Complete clinical remission rate, Adverse events, Serious adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

A: Intra-arterial chemoradiotherapy
Radiotherapy: a total dose of 70 Gy in a fraction of 2 Gy five times weekly
Intra-arterial chemotherapy: CDDP100 mg/m2/day, once a week, 7 times concurrently with radiotherapy

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) primary lesion located at maxillary sinus
2) histologically proven squamous cell carcinoma
3) clinical stage T4aN0M0 or T4bN0M0
4) no severe carotid stenosis evaluated by ultrasonography
5) age between 20 and 75 years old (dose finding phase), age between 20 and 80 years old (confirmatory phase),
6) ECOG performance status of 0 or 1
7) no prior therapy for maxillary sinus cancer
8) no prior radiation therapy to the head and neck, and the brain
9) no prior chemotherapy for any other malignancies
10) sufficient organ function
11) normal electrocardiogram
12) suitable for angiography
13) satisfy normal tissue radiation dose constraints such as at least ipsilateral eyeball and optic nerve, spinal cord, brainstem, and chiasma
14) written informed consent.

Key exclusion criteria

1) simultaneous or metachronous (within 5 years) double cancers except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers
2) active bacterial or fungous infection
3) body temperature >= 38 degrees Celsius
4) women during pregnancy or breastfeeding
5) psychosis
6) requiring systemic steroids medication or immunosuppressant medication
7) diabetes mellitus poorly controlled
8) poorly controlled hypertension
9) angina pectoris attack within 3 weeks or myocardial infarction within 6 months
10) positive HBs antigen

Target sample size

145


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Homma

Organization

Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan

TEL

011-706-5958

Email

ak-homma@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiro Homma

Organization

JCOG1212 Coordinating Office

Division name

Department of Otolaryngology-Head and Neck Surgery, Hokkaido University

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan

TEL

011-706-5958

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

北海道大学病院(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
宮城県立がんセンター(宮城県)
福島県立医科大学附属病院(福島県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
国立病院機構東京医療センター(東京都)
東京医科歯科大学(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
奈良県立医科大学(奈良県)
広島大学病院(広島県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 14 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

Open public recruiting

Date of protocol fixation

2014 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 14 Day

Last follow-up date

2024 Year 10 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 14 Day

Last modified on

2017 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name