UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
骨巨細胞腫の肺転移に対し転移巣切除か保存的加療のどちらが良いか？システマティックレビュー

英語
Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review

一般向け試験名略称/Acronym

日本語
骨巨細胞腫の肺転移：システマティックレビュー

英語
Lung metastases from GCTB: A systematic review

科学的試験名/Scientific Title

日本語
骨巨細胞腫の肺転移に対し転移巣切除か保存的加療のどちらが良いか？システマティックレビュー

英語
Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review

科学的試験名略称/Scientific Title:Acronym

日本語
骨巨細胞腫の肺転移：システマティックレビュー

英語
Lung metastases from GCTB: A systematic review

試験実施地域/Region

日本/Japan	欧州/Europe

対象疾患名/Condition

日本語
骨巨細胞腫の肺転移

英語
Lung metastases from giant cell tumor of bone

疾患区分1/Classification by specialty

呼吸器外科学/Chest surgery	整形外科学/Orthopedics

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
骨巨細胞腫の肺転移に対し転移巣切除と保存的加療のどちらが腫瘍死を減らすため有用かを検証する。

英語
We are going to perform a systematic review of comparative studies to determine whether metastasectomy can decrease the tumor-related death in patients with operable lung metastasis from GCTB compared with non-metastasectomy.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

その他/Others

試験の性質2/Trial characteristics_2

その他/Others

試験のフェーズ/Developmental phase

該当せず/Not applicable

主要アウトカム評価項目/Primary outcomes

日本語
腫瘍死

英語
We counted only tumor-related death as the outcome, and excluded the death unrelated to disease and the death related to chemotherapy.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

適用なし/Not applicable

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
切除可能な肺転移

英語
All comparative reports examining tumor-related death in patients who had giant cell tumors of bone and operable lung metastases and were treated with metastasectomy and non-metastasectomy, were included. Metastasectomy group included patients treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy.Non-metastasectomy group included patients treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy.We included human studies and articles with clearly-described death following treatment for lung metastases. We counted only tumor-related death, and excluded the death unrelated to disease and the death related to chemotherapy.

除外基準/Key exclusion criteria

日本語
切除不可能な肺転移に対し保存的加療を受けた患者群、比較群のない研究、５例以下の症例報告、英語・日本語以外の論文は除外した。

英語
The patients who had inoperable lung metastases and were treated with observation, chemotherapy, or radiotherapy, were excluded.We excluded studies without a comparison group, those without a report of tumor-related death, isolated case reports or case series including fewer than five patients and non-English and non-Japanese language abstracts. We did not place any restrictions on the date of publication.

目標参加者数/Target sample size

100

責任研究者/Name of lead principal investigator

日本語

名	真治
ミドルネーム
姓	塚本

英語

名	Shinji
ミドルネーム
姓	Tsukamoto

所属組織/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

所属部署/Division name

日本語
整形外科

英語
Department of Orthopaedic Surgery

郵便番号/Zip code

634-8521

住所/Address

日本語
奈良県橿原市四条町８４０番地

英語
840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan

電話/TEL

0744-22-3051

Email/Email

shinji104@mail.goo.ne.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	真治
ミドルネーム
姓	塚本

英語

名	Shinji
ミドルネーム
姓	Tsukamoto

組織名/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

部署名/Division name

日本語
整形外科

英語
Department of Orthopaedic Surgery

郵便番号/Zip code

634-8521

住所/Address

日本語
奈良県橿原市四条町８４０番地

英語
840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan

電話/TEL

0744-22-3051

試験のホームページURL/Homepage URL

Email/Email

shinji104@mail.goo.ne.jp

機関名/Institute

日本語
その他

英語
Nara Medical University

機関名/Institute
（機関選択不可の場合）

日本語
奈良県立医科大学

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Nara Medical University

機関名/Organization
（機関選択不可の場合）

日本語
奈良県立医科大学

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

住所/Address

日本語
奈良県橿原市四条町８４０番地

英語
840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan

電話/Tel

0744-22-3051

Email/Email

shinji104@mail.goo.ne.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2019

年

12

月

09

日

プロトコル掲載URL/URL releasing protocol

Orthopedics 2021

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

Orthopedics 2021

組み入れ参加者数/Number of participants that the trial has enrolled

138

主な結果/Results

日本語
The mortality of the patients was similar
in the metastasectomy and the nonmetastasectomy groups; the proportion
of patients in the metastasectomy group
who died of disease was 7.1% (6 of 85)
compared with 17.0% (9 of 53) in the
non-metastasectomy group; the overall
pooled OR was 0.64 (95% CI, 0.24-1.68;
P=.360), and the heterogeneity I2 was 0%
(Figure A, available in the online version
of the article).

英語
The mortality of the patients was similar
in the metastasectomy and the nonmetastasectomy groups; the proportion
of patients in the metastasectomy group
who died of disease was 7.1% (6 of 85)
compared with 17.0% (9 of 53) in the
non-metastasectomy group; the overall
pooled OR was 0.64 (95% CI, 0.24-1.68;
P=.360), and the heterogeneity I2 was 0%
(Figure A, available in the online version
of the article).

主な結果入力日/Results date posted

2021

年

06

月

10

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
NA

英語
NA

参加者の流れ/Participant flow

日本語
NA

英語
NA

有害事象/Adverse events

日本語
NA

英語
NA

評価項目/Outcome measures

日本語
NA

英語
NA

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2019

年

12

月

09

日

倫理委員会による承認日/Date of IRB

2019

年

12

月

09

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

12

月

09

日

フォロー終了(予定)日/Last follow-up date

2019

年

12

月

31

日

入力終了(予定)日/Date of closure to data entry

2020

年

01

月

05

日

データ固定（予定）日/Date trial data considered complete

2020

年

01

月

05

日

解析終了(予定)日/Date analysis concluded

2020

年

01

月

10

日

その他関連情報/Other related information

日本語
Two authors (ST and AK) independently selected the studies and extracted the data. In cases of disagreement, a consensus was either achieved between them, or by consulting a third author. A data collection sheet was used to collate the following data: (1) basic data: authors, year of publication, name of publishing journal, type of study, and total number of patients, and the length of follow-up; (2) number of patients in the metastasectomy and the non-metastasectomy groups, and proportions of patients with tumor-related death in the metastasectomy and the non-metastasectomy groups; the each total number and tumor-related death number of patients who were treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy in the metastasectomy group; the each total number and tumor-related death number of patients who were treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy in the non-metastasectomy group; (3) characteristics of the metastasectomy and the non-metastasectomy groups such as interval to lung metastases, number and extent of the lung lesions (solitary or multiple lesion, unilateral or bilateral lesion), and tendency to increase of the lung lesion (progression, stable or regression); (4) resection status (complete or incomplete resection) in the metastasectomy group; the chemotherapy regimen.

英語
Two authors (ST and AK) independently selected the studies and extracted the data. In cases of disagreement, a consensus was either achieved between them, or by consulting a third author. A data collection sheet was used to collate the following data: (1) basic data: authors, year of publication, name of publishing journal, type of study, and total number of patients, and the length of follow-up; (2) number of patients in the metastasectomy and the non-metastasectomy groups, and proportions of patients with tumor-related death in the metastasectomy and the non-metastasectomy groups; the each total number and tumor-related death number of patients who were treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy in the metastasectomy group; the each total number and tumor-related death number of patients who were treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy in the non-metastasectomy group; (3) characteristics of the metastasectomy and the non-metastasectomy groups such as interval to lung metastases, number and extent of the lung lesions (solitary or multiple lesion, unilateral or bilateral lesion), and tendency to increase of the lung lesion (progression, stable or regression); (4) resection status (complete or incomplete resection) in the metastasectomy group; the chemotherapy regimen.

登録日時/Registered date

2019

年

12

月

09

日

最終更新日/Last modified on

2021

年

12

月

10

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044274

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044274