UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014274
Receipt number R000016433
Scientific Title A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)
Date of disclosure of the study information 2014/06/16
Last modified on 2021/01/05 16:18:06

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Basic information

Public title

A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)

Acronym

A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)

Scientific Title

A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)

Scientific Title:Acronym

A non-randomized confirmatory study of intensity modulated radiation therapy (IMRT) for T1-2N0-1M0 oropharyngeal cancer (OPC) (JCOG1208, IMRT for Early OPC)

Region

Japan


Condition

Condition

Oropharyngeal cancer

Classification by specialty

Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and the safety of radiotherapy with Intensity Modulated Radiation Therapy (IMRT) in patients with T1-2N0-1M0 (UICC 7th edition, 2009) oropharyngeal cancer (Tonsil without base of tongue invasion, Base of tongue, Soft palate)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival (%3-year overall survival)

Key secondary outcomes

Progression-free survival (%3-year progression-free survival), loco-regional progression-free survival (%3-year loco-regional progression-free survival), loco-regional control (%3-year loco-regional control), site of first progression, proportion of protocol treatment completion within recommended treatment time, grade 2 or more xerostomia (evaluated at 3, 6, 12, 18, 24, 36 months from IMRT start, CTCAE ver4.0-JCOG), 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

Maneuver

Interventions/Control_1

Radiotherapy with two-step IMRT (70 Gy/ 35 fr/ 47 days).

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

i) Clinically diagnosed of oropharyngeal cancer
ii) Pathologically proven squamous cell carcinoma based on the biopsy from the tumor
iii) Subsites including tonsil without invasion to the base of tongue, base of the tongue, or soft palate
iv) cT1-2N0-1M0 (UICC 7th edition, 2009), no synchronous double/multiple cancer
v) In case of cN0, not a candidate for transoral approach surgery
vi) Planned treatment period within 52 days
vii) Aged 20 to 80 years old
viii) ECOG PS of 0 or 1
ix) No prior chemotherapy for any malignancies, no prior radiation therapy for brain, head or neck region, no prior surgery for head and neck cancer
x) Sufficient organ functions
xi) Written informed consent

Key exclusion criteria

i) Simultaneous or metachronous (within the past 5 years) malignancies
ii) Infectious disease requiring systemic treatment
iii) Body temperature of 38 degrees Celsius or higher
iv) Pregnant or lactating women or women of childbearing potential
v) Psychiatric disease
vi) Continuous systemic steroids or immunosuppressive medication
vii) History of collagen diseases including rheumatism
viii) Diabetes mellitus treated with routine administration of insulin or poorly controlled
ix) Treated with hemodialysis
x) Serious complications (COPD, pulmonary fibrosis, heart failure, etc.)
xi) Myocardial infarction within 6 months or unstable angina pectoris
xii) Cardiac pacemaker or ICD recipients

Target sample size

57


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasumasa Nishimura

Organization

Kinki University Faculty of Medicine

Division name

Department of Radiation Oncology

Zip code


Address

377-2, Ono-higashi, Osaka-Sayama, Osaka, 589-8511, Japan

TEL

072-366-0221(3132)(3130)

Email

ynishi@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoaki Nakamura

Organization

JCOG1208 Coordinating Office

Division name

Department of Radiation Oncology, Kansai Medical University Hospital

Zip code


Address

2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan

TEL

072-804-0101

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)
札幌医科大学(北海道)
東北大学病院(宮城県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
昭和大学病院(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)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
北里大学医学部(神奈川県)
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)
京都大学医学部附属病院(京都府)
近畿大学医学部(大阪府)
兵庫県立がんセンター(兵庫県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 16 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

No longer recruiting

Date of protocol fixation

2014 Year 04 Month 07 Day

Date of IRB

2014 Year 05 Month 22 Day

Anticipated trial start date

2014 Year 06 Month 16 Day

Last follow-up date

2023 Year 03 Month 16 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 06 Month 16 Day

Last modified on

2021 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016433


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name