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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023645
Receipt No. R000027040
Scientific Title Phase I trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with multiple metastatic non-small cell lung cancer.
Date of disclosure of the study information 2016/08/17
Last modified on 2017/08/20

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Basic information
Public title Phase I trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with multiple metastatic non-small cell lung cancer.
Acronym NIVOSTLUC-1
Scientific Title Phase I trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with multiple metastatic non-small cell lung cancer.
Scientific Title:Acronym NIVOSTLUC-1
Region
Japan

Condition
Condition non-small cell lung cancer with two or more lesions including at least lung or pluera
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety of a treatment of Nivolumab combined with stereotactic body radiotherapy for thoracic lesion in patients with advanced non-small cell lung cancer with two or more lesions including at least lung or pluera
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The ratio of cases with grade four/five or aggravation of two or more toxicity grade within 24 weeks after the start of therapy.
Key secondary outcomes The reduction ratio in size of irradiated lesions and the non-irradiated lesion at 24 weeks after start of treatment.
The change of the tumor marker level as of 24 weeks after start of treatment and stereotactic body radiotherapy.
The expression ratio of PD-L1 in the tumor before the start of treatment.
The ratio of case with one or two aggravation of toxicity grade within 24 weeks after the start of therapy.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Total 12 courses of Nivolumab(3 mg/kg,by 2weeks). Performing stereotactic body radiation therapy (more than 5 Gy/fraction(total biological effective dose of 40-55Gy within 2weeks) for lung or a pleura lesion at the third course.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Cytologically or histologically confirmed non-small-cell lung cancer
2)At least two measurable lesions including at least one lung or thoracic lesion.
3)Radical radiotherapy not applicable
4)Aged 20 or more
5)ECOG Performance status of 0-2
6)Judgement by Radiation-oncologist for indication and safely of irradiation
7)Satisfication of the following criteria in the latest labo data within 7 days of the registration:1.WBC=3000 per mm3 or more,2.Hb=9.0g per dl or more, 3.PLT=100000 per mm3 or more, 4.Serum Creatinine=1.5mg per dl or less, 5.Total bililubine=1.5mg per dl or less, 6.GOT(AST)=100IU per L or less, 7.GPT(ALT)=100IU per L or less, 8.SpO2=93% or more(room ai)
8)Written informed consent after enough explanation
Key exclusion criteria 1)Active double cancer(except for some early or cured cancer as followe:carcinoma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer)
2)Serious heart disease,uncontrolled diabetes mellitus despite continuing treatment of insulin,cardiac infarction within 6 months before enrollment,uncontrolled hypertension,history of severe infections,watery diarrhea,paresis of intestine,ileus,autoimmune disease,other severe complications
3)Radiographically (chest X-P or CT image) confirmed interstitial pneumonitis or pulmonary fibrosis
4)Severe emphysema, chronic bronchitis, asthma
5)Continuous systemic administration of steroid
6)Severe mental illness
7)women who are or may be pregnant or in lactatoin
8)Unsuitable patients judged by the attending physician or radiation-oncologist(previous irradiation is ignored)
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Onishi
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Radiology
Zip code
Address 1110, Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Email honishi@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kan Marino
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Radiology
Zip code
Address 1110, Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Homepage URL
Email marino@yamanashi.ac.jp

Sponsor
Institute Department of Radiology, University of Yamanashi
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb Company
Organization
Division
Category of Funding Organization Profit organization
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 山梨大学医学部附属病院(山梨県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 17 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 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
2016 Year 08 Month 16 Day
Last modified on
2017 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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