UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023645 |
|---|---|
| Receipt number | 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 22:21:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
marino@yamanashi.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027040
