UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016795 |
|---|---|
| Receipt number | 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 22:13:52 |
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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
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
rijun@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical university
Institute
Department
Personal name
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
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
Value
https://center6.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 |
