UMIN-CTR Clinical Trial

Public title

Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Acronym

Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Scientific Title

Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Scientific Title:Acronym

Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

Region

Japan

Condition

T1-2N0M0 glottic cancer

Classification by specialty

Oto-rhino-laryngology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the non-inferiority of survival benefit of accelerated fractonation radiation therapy (2.4 Gy/fr) compared with conventional fractonation radiation therapy (2 Gy/fr) for patients with T1-2N0M0 glottic squamous cell carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

3-year progression-free survival

Key secondary outcomes

overall survival, local progression-free survival, disease-free survival, survival with preserved voice function, complete response rate, proportion of treatment completion in specific term, adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A: Conventional fractionation radiation therapy (2 Gy/fr; T1:66 Gy/33 fr, T2:70 Gy/35 fr)

Interventions/Control_2

B: Accelerated fractionation radiation therapy (2.4 Gy/fr; T1: 60 Gy/25 fr, T2: 64.8 Gy/27 fr)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Primary tumor site is vocal cord.
2) Histologically proven squamous cell carcinoma.
3) Extent of primary tumor is evaluated as T1 or T2 without impaired cord morbidity.
4) Clinical N0/M0.
5) Planned radiation therapy fulfill limitation of overall treatment time.
6) Aged 20 to 80 years old.
7) Performance status of 0 or 1.
8) No prior surgery or radiation therapy against larynx.
9) No prior chemotherapy against any malignancies.
10) Sufficient organ functions.
11) Written informed consent.

Key exclusion criteria

1) Active bacterial or fungous infection.
2) Simultaneous or metachronous (within 5 years) double cancers.
3) Women during pregnancy or breast-feeding.
4) Psychosis.
5) Systemic steroids medication.
6) History of collagen disease except for rheumatism.
7) Uncontrollable diabetes mellitus or administration of insulin.
8) Hemodialysis medication
9) Uncontrollable hypertension.
10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.

Target sample size

360

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Kagami

Organization

National Cancer Center Hospital

Division name

Radiation Oncology Division

Zip code

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN

TEL

03-3542-2511

Email

Name of contact person

1st name
Middle name
Last name	Naoto Shikama

Organization

JCOG0701 Coordinating Office

Division name

Saku Central Hospital

Zip code

Address

197, Usuda, Saku-City, Nagano, 384-0301, Japan

TEL

0267-82-3131

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

札幌医科大学（北海道）
東北大学病院（宮城県）
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
獨協医科大学越谷病院（）
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）
東京女子医科大学（東京都）
国立病院機構東京医療センター（東京都）
慶應義塾大学病院（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）
北里大学医学部（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
山梨大学医学部（山梨県）
信州大学医学部（長野県）
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）
大阪大学医学部（大阪府）
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）
大阪市立総合医療センター（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）
琉球大学医学部（沖縄県）

Date of disclosure of the study information

2007

Year

09

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2007

Year

08

Month

13

Day

Date of IRB

Anticipated trial start date

2007

Year

09

Month

01

Day

Last follow-up date

2014

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

09

Month

05

Day

Last modified on

2013

Year

07

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000975