UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007842 |
|---|---|
| Receipt number | R000009236 |
| Scientific Title | A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC) for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI) |
| Date of disclosure of the study information | 2012/04/27 |
| Last modified on | 2012/11/30 12:48:31 |
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Basic information
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
Condition
extranodal NK/T-cell lymphoma, nasal type
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
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
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
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
Eligibility
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
Research contact person
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
Public contact
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/
waniwani@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
Other related information
http://jco.ascopubs.org/content/30/32/4044.2.full
Management information
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
