UMIN-CTR Clinical Trial

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

giant cell tumor of bone

Classification by specialty

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Toshifumi
Middle name
Last name	Ozaki

Organization

Okayama University Hospital

Division name

Department of Orthopaedic Surgery

Zip code

700-8558

Address

2-5-1 Shikata -cho, Kita-ku, Okayama

TEL

086-235-7273(86-235-7273)

Email

tozaki@md.okayama-u.ac.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Urakawa

Organization

JCOG1610 Coordinating Office

Division name

Department of Orthopaedic Surgery, Nagoya University

Zip code

466-8550

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

10

Month

06

Day

URL releasing protocol

This protocol is not open to the public.

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35472141/

Number of participants that the trial has enrolled

18

Results

See the datails via "URL related to results and publications" above.

Results date posted

2023

Year

10

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html

Participant flow

Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html

Adverse events

Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html

Outcome measures

Please refer to the "clinical study report (CSR)" posted on the following website.
https://jcog.jp/clinicaltrial/index.html

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

07

Day

Date of IRB

2017

Year

09

Month

26

Day

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 related information

Registered date

2017

Year

10

Month

06

Day

Last modified on

2023

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033650