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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029451
Receipt No. R000033650
Scientific Title A randomized phase III study of denosumab before curettage for giant cell tumor of bone (JCOG1610, Preoperative Denosumab for GCTB RPIII)
Date of disclosure of the study information 2017/10/06
Last modified on 2017/10/06

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Basic information
Public title A randomized phase III study of denosumab before curettage for giant cell tumor of bone (JCOG1610, Preoperative Denosumab for GCTB RPIII)
Acronym A randomized phase III study of denosumab before curettage for giant cell tumor of bone (JCOG1610, Preoperative Denosumab for GCTB RPIII)
Scientific Title A randomized phase III study of denosumab before curettage for giant cell tumor of bone (JCOG1610, Preoperative Denosumab for GCTB RPIII)
Scientific Title:Acronym A randomized phase III study of denosumab before curettage for giant cell tumor of bone (JCOG1610, Preoperative Denosumab for GCTB RPIII)
Region
Japan

Condition
Condition giant cell tumor of bone
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of preoperative denosumab in patients with giant cell tumor of bone treated by curettage with adjuvant local therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Overall survival, Joint-preserved survival, Local relapse-free survival, Metastasis-free survival, Adverse events, Serious adverse events, Surgical and postoperative complications, Discontinuance of denosumab

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 A: Surgery (Curettage+Adjuvant local therapy)
Interventions/Control_2 B: Preoperative denosumab+Surgery (Curettage+Adjuvant local therapy)

Preoperative denosumab is administered at a dose of 120 mg on day 1, 8, 15, 29, and 57.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Diagnosed as giant cell tumor of bone (WHO classification) using image and biopsy specimen
2) One HE staining and 10 or more unstained tumor tissue slides are available (One HE staining and 5 or more unstained tumor tissue slides are available in a case of needle biopsy)
3) No distant metastases in chest CT
4) Tumor in the extremities
5) Single tumor
6) Primary tumor (Campanacci GradeII and GradeIII) , first local recurrent tumor, or second local recurrent tumor
7) Age >= 20 and =< 70
8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9) Fracture =<grade 2 (CTCAEv4.0), controllable pain by drug, and no instability in the fracture site
10) Tumor which can be treated by curettage
11) No history of denosumab
12) No history of bisphosphonate within 1 year
13) No history of osteonecrosis of the jaw
14) Sufficient organ function
15) No abnormal ECG findings
16) No possibility of pregnancy or agreement of birth control during treatments, and without breast-feeding (this applies to only women)
17) Written informed consent
18) No history of participation in this study
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Brown tumor or Paget's disease of bone
5) Psychiatric disease
6) Patients requiring systemic steroid medication or the other immunosuppressive drug
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Ozaki, MD, PhD
Organization Okayama University Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 2-5-1 Shikata -cho, Kita-ku, Okayama
TEL 086-235-7273(86-235-7273)
Email tozaki@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Urakawa, MD, PhD
Organization JCOG1610 Coordinating Office
Division name Department of Orthopaedic Surgery, Nagoya University
Zip code
Address 65 Tsurumai-cho Showa-ku, Nagoya
TEL 052-744-1908(81-52-744-1908)
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
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 国立病院機構北海道がんセンター(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
日本大学医学部附属板橋病院(東京都)
杏林大学医学部(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
帝京大学医学部(東京都)
横浜市立大学附属病院(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
三重大学医学部(三重県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪国際がんセンター(大阪府)
神戸大学医学部(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
香川大学医学部(香川県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
九州労災病院(福岡県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 06 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 08 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 06 Day
Last follow-up date
2027 Year 04 Month 06 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 10 Month 06 Day
Last modified on
2017 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033650

Research Plan
Registered date File name

Research case data specifications
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Research case data
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