UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025878 |
|---|---|
| Receipt number | 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 | 2021/01/30 09:45:50 |
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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
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
isekine@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029747
