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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025878
Receipt No. R000029747
Scientific Title Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Date of disclosure of the study information 2017/02/01
Last modified on 2017/07/30

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Basic information
Public title Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Acronym RT-Nivo NSCLC phase II
Scientific Title Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Scientific Title:Acronym RT-Nivo NSCLC phase II
Region
Japan

Condition
Condition non-small cell lung cancer with bone metastasis
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate antitumor effects of nivolumab following palliative radiation to bone metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Progression free survival, overall survival, safety, and tolerability

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Radiation therapy 20 Gy/5 fractions to bone metastasis, followed by nivolumab 3mg/kg administered 6 to 24 hours after the end of the radiation therapy. Then, nivolumab is given every two weeks until disease progression or stop of the treatment because of toxicity.
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) a histological or cytological diagnosis of non-small cell lung cancer
2) having bone metastasis suitable for palliative radiation therapy which had not been radiated
3) age above 20 years old
4) ECOG performance status of 0-2
5) Prior platinum-containing chemotherapy
6) Adequate organ function as documented by a WBC count of 3,000/microL or higher, hemoglobin of 9.0 g/dL or higher, platelet count of 100,000/microL or higher, serum creatinine of 1.5 mg/dL or lower, hepatic transaminases of 100 IU/L or lower, alanine aminotransferase of 100 IU/L or lower, total serum bilirubin of 1.8 mg/dL or lower, and PaO2 of 70 Torr or higher or SpO2 of 93% or higher at room air
7) having a measurable disease with CT or MRI
8) written informed consent
Key exclusion criteria 1) Positive for epidermal grow factor receptor activating mutation or ALK re-arrangement
2) Active malignancies within 2 years
3) Active infection requiring intravenous systemic therapy or hospital admission
4) A history of interstitial lung disease
5) A history of active, known autoimmune disease.
6) Requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications.
7) Active CNS metastasis
8) Carcinomatous meningitis
9) Positive for HBs antigen or HBV-DNA positive
10) Positive for HCV antibody
11) Pregnant or breast-feeding women
12) Any other patients whom the doctor judged to be unsuitable for this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Sekine
Organization University of Tsukuba Hospital
Division name Department of Medical Oncology
Zip code
Address Amakubo 2-1-1, Tsukuba-shi, ibaraki
TEL 029-853-3900
Email isekine@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuo Sekine
Organization University of Tsukuba Hospitgal
Division name Department of Medical Oncology
Zip code
Address Amakubo 2-1-1, Tsukuba-shi, ibaraki
TEL 029-853-3900
Homepage URL
Email isekine@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2017 Year 02 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 07 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
2017 Year 01 Month 27 Day
Last modified on
2017 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029747

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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