UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of palliative radiotherapy combined with Zoledronic Acid Hydrate for metastatic bone tumor from renal cell carcinoma
Acronym	Phase II study of Zometa+RT for bone metastasis from RCC
Scientific Title	Phase II study of palliative radiotherapy combined with Zoledronic Acid Hydrate for metastatic bone tumor from renal cell carcinoma
Scientific Title:Acronym	Phase II study of Zometa+RT for bone metastasis from RCC
Region	Japan

Condition
Condition	Renal cancer
Classification by specialty	Orthopedics Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To report Skeletal related event for bone metastasis treated with radiotherapy and Zoredronic acid hydrate in renal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Skeletal-related event
Key secondary outcomes

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 Device,equipment
Interventions/Control_1	Radiotherapy+Zoledronic acid hydrate
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)Renal cell carcinoma 2)Radiotherapy is planned for bone metastasis 3)No new systematic therapy within 4 weeks 4)White blood cell >=2000/mm3 Platelet >=50000/mm3 Hemoglobin >=8.0g/dl Creatinine crearance >=30mL/min 5)PS0-2 6)Informed consent
Key exclusion criteria	1)Surgery is needed for bone metastasis 2)Hypercalcemia 3)Dental problem
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideyuki Harada
Organization	Shizuoka Cancer Center
Division name	Radiation Oncology
Zip code
Address	Shimonagakubo1007 Nagaizumi-cho Sunto-gun Shizuoka
TEL	81559895222
Email	h.harada@scchr.jp

Public contact
Name of contact person	1st name Middle name Last name Hideyuki Harada
Organization	Shizuoka Cancer Center
Division name	Radiation Oncology
Zip code
Address	1007 shimonagakubo Nagaizumi-cho, Sunto-gun, Shizuoka, JAPAN
TEL	810559895222
Homepage URL
Email	h.harada@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center Japanese Radiation Oncology Study Group
Institute
Department

Funding Source
Organization	Japanese Radiation Oncology Study Group
Organization
Division
Category of Funding Organization	Other
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	YES
Study ID_1	JROSG11-1
Org. issuing International ID_1	Japanese Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 25 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	Main results already published
Date of protocol fixation	2012 Year 02 Month 17 Day
Date of IRB	2012 Year 04 Month 24 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2017 Year 12 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	2012 Year 04 Month 25 Day
Last modified on	2021 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009233