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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016795
Receipt No. R000019496
Scientific Title A phase I/II study of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for localized nasal NK/T-cell lymphoma
Date of disclosure of the study information 2015/04/01
Last modified on 2018/09/20

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Basic information
Public title A phase I/II study of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for localized nasal NK/T-cell lymphoma
Acronym A phase I/II study of arterial infusion concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma (MPVIC-P/RT)
Scientific Title A phase I/II study of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for localized nasal NK/T-cell lymphoma
Scientific Title:Acronym A phase I/II study of arterial infusion concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma (MPVIC-P/RT)
Region
Japan

Condition
Condition localized nasal NK/T-cell lymphoma
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I/II trial to evaluate efficacy and toxicity of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for patients with newly-diagnosed, localized nasal NK/T-cell lymphoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Toxicity, 2-year overall survival rate
Key secondary outcomes Complete response rate, 2-year progression-free survival rate, pattern of failure, 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 Concurrent intra-arterial MPVIC-P chemotherapy and radiotherapy with 54Gy
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
75 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 involvemen
4) Aged 20 to 75 years old
5) Performance status (PS) of 0-1 on ECOG (Eastern Cooperative Oncology Group) scale
6) No prior chemotherapy or radiotherapy
7) Patients not requiring systemic corticosteroid therapy after registration
8) Adequate organ function
9) Written informed consent
Key exclusion criteria 1) Clinical symptoms of Central nervous system involvement
2)Uncontrollable diabetes mellitus and/or hypertension
3) Uncontrollable myocardial infarction, angina, and/or cardiomyopathy
4) Positive test for HIV antibody
5) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
6) Severe infection
7) Liver cirrhosis
8) Other active malignancies
9) Pregnant, possible pregnant, or breastfeeding woman
10) Use of major tranquilizer, antidepressant, or antimanic
11) Severe psychosis
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miki Takahara
Organization Asahikawa Medical university
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address Midorigaoka higashi 2-1-1-1 Asahikawa, Hokkaido, Japan
TEL 0166-68-2554
Email miki@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Nagato
Organization Asahikawa Medical university
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address Midorigaoka higashi 2-1-1-1 Asahikawa, Hokkaido, Japan
TEL 0166-68-2554
Homepage URL
Email rijun@asahikawa-med.ac.jp

Sponsor
Institute Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 旭川医科大学耳鼻咽喉科・頭頸部外科

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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 Completed
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 13 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/09/20 180920 NKT動注.xlsx


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