UMIN-CTR Clinical Trial

Public title

A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC)
for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

Acronym

A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC)
for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

Scientific Title

A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC)
for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

Scientific Title:Acronym

A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC)
for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

Region

Japan

Condition

extranodal NK/T-cell lymphoma, nasal type

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase I/II trial to evaluate efficacy and toxicity of concurrent chemoradiotherapy (RT-DeVIC) for patients with newly-diagnosed, localized nasal NK/T-cell lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Phase I portion: toxicity
Phase II portion: 2-year overall survival rate

Key secondary outcomes

Phase II portion: Complete response rate, 2-year progression-free survival rate, 2-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation
Long-term follow-up: 5-year overall survival rate, 5-year progression-free survival rate, 5-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Concurrent chemoradiotherapy comprising radiotherapy of 50 - 50.4 Gy and 3 cycles of DeVIC chemotherapy

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

Age-lower limit

20

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed extranodal NK/T-cell lymphoma, nasal type
2) Lymphomatous involvement in nasal cavity and/or its adjacent site(s)
3) Stage IE or contiguous stage IIE with cervical lymph node involvement
4) Aged 20 to 69 years old
5) Performance status (PS) of 0-2 on ECOG (Eastern Cooperative Oncology Group) scale
6) Measureable lesion present
7) No prior chemotherapy or radiotherapy
8) Patients not requiring systemic corticosteroid therapy after registration
9) Adequate organ function
10) Written informed consent

Key exclusion criteria

1) Clinical symptoms of Central nervous system involvement
2) Uncontrollable diabetes mellitus
3) Uncontrollable hypertension
4) History of myocardial infarction or angina, and/or cardiomyopathy, and/or arrhythmia treated with antiarrhythmic
5) Positive test for HBs antigen
6) Positive test for HIV antibody
7) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
8) Severe infection
9) Liver cirrhosis
10) Other active malignancies
11) Pregnant, possible pregnant, or breastfeeding woman
12) Use of major tranquilizer, antidepressant, or antimanic
13) Severe psychosis
14) Patients or their families, and/or attending physicians hoping hematopoietic stem cell transplantation after obtained responses by RT-DeVIC

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo Oshimi, M.D., Ph.D.

Organization

Juntendo University

Division name

Department of Hematology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1068

Email

Name of contact person

1st name
Middle name
Last name	Motoko Yamaguchi, M.D., Ph.D.

Organization

JCOG0211-DI Coordinating Office

Division name

Department of Hematology and Oncology, Mie University Graduate School of Medicine

Zip code

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-231-5418

Homepage URL

http://www.jcog.jp/

Email

waniwani@clin.medic.mie-u.ac.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

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）
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）
杏林大学医学部（東京都）
東京慈恵会医科大学附属病院（東京都）
順天堂大学医学部（東京都）
東海大学医学部（神奈川県）
金沢医科大学（石川県）
名古屋大学医学部（愛知県）
三重大学医学部（三重県）
滋賀県立成人病センター（滋賀県）
愛媛大学医学部附属病院（愛媛県）
産業医科大学（福岡県）
佐賀大学医学部（佐賀県）
熊本大学医学部（熊本県）
国立病院機構熊本医療センター（熊本県）
JCOGホームページ（http://www.jcog.jp/basic/partner/group/mem_rtsg.htm）参照

Date of disclosure of the study information

2012

Year

04

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://jco.ascopubs.org/content/27/33/5594

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

Completed

Date of protocol fixation

2003

Year

06

Month

19

Day

Date of IRB

Anticipated trial start date

2003

Year

09

Month

01

Day

Last follow-up date

2011

Year

12

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

http://jco.ascopubs.org/content/30/32/4044.2.full

Registered date

2012

Year

04

Month

26

Day

Last modified on

2012

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009236