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
遠隔転移のない悪性骨巨細胞腫に対する補助化学療法の効果：システマティックレビュー

英語
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review

一般向け試験名略称/Acronym

日本語
遠隔転移のない悪性骨巨細胞腫に対する補助化学療法の効果：システマティックレビュー

英語
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review

科学的試験名/Scientific Title

日本語
遠隔転移のない悪性骨巨細胞腫に対する補助化学療法の効果：システマティックレビュー

英語
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review

科学的試験名略称/Scientific Title:Acronym

日本語
遠隔転移のない悪性骨巨細胞腫に対する補助化学療法の効果：システマティックレビュー

英語
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: 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
悪性骨巨細胞腫

英語
malignant giant cell tumor of bone

疾患区分1/Classification by specialty

血液・腫瘍内科学/Hematology and clinical oncology	整形外科学/Orthopedics

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
To investigate the efficacy of adjuvant chemotherapy for localized malignant GCTB, we performed a systematic review of studies comparing mortality in patients who underwent wide resection or wide resection plus adjuvant chemotherapy for primary and secondary localized malignant GCTB respectively.

英語
To investigate the efficacy of adjuvant chemotherapy for localized malignant GCTB, we performed a systematic review of studies comparing mortality in patients who underwent wide resection or wide resection plus adjuvant chemotherapy for primary and secondary localized malignant GCTB respectively.

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

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
Number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths;

英語
Number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths;

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
Patients who underwent surgery alone for the primary tumor of malignant GCTB and chemotherapy for distant metastases that occurred during the course of the disease were classified as the surgery alone group. Regarding the number of deaths, only deaths due to tumor were counted. Only literatures written in English and Japanese were included, and no restrictions were placed on the year of publication.

英語
Patients who underwent surgery alone for the primary tumor of malignant GCTB and chemotherapy for distant metastases that occurred during the course of the disease were classified as the surgery alone group. Regarding the number of deaths, only deaths due to tumor were counted. Only literatures written in English and Japanese were included, and no restrictions were placed on the year of publication.

除外基準/Key exclusion criteria

日本語
Patients with distant metastasis at the time of diagnosis of malignant GCTB were excluded. Patients with an unclear prognosis were also excluded.

英語
Patients with distant metastasis at the time of diagnosis of malignant GCTB were excluded. Patients with an unclear prognosis were also excluded.

目標参加者数/Target sample size

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

+81-744-22-3051

Email/Email

sh104@naramed-u.ac.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

+81-744-22-3051

試験のホームページURL/Homepage URL

Email/Email

sh104@naramed-u.ac.jp

機関名/Institute

日本語
奈良県立医科大学

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
Not applicable

機関名/Organization
（機関選択不可の場合）

日本語
該当なし

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
Not applicable

英語
Not applicable

住所/Address

日本語
Not applicable

英語
Not applicable

電話/Tel

Not applicable

Email/Email

Not applicable

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

2021

年

08

月

02

日

プロトコル掲載URL/URL releasing protocol

doi.org/10.3390/cancers13215410

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

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

112

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

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

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

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

2021

年

08

月

02

日

倫理委員会による承認日/Date of IRB

2021

年

08

月

02

日

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

2021

年

08

月

02

日

フォロー終了(予定)日/Last follow-up date

2021

年

08

月

02

日

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

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

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
Literature search and study selection
Pubmed, Embase, and Cochrane Central Register　of Controlled Trials (CENTRAL)　databases were used to search the literature according to a systematic search strategy on 28 July 2021. In addition, the bibliographies of the retrieved literatures were used to identify other relevant studies. Publication bias was assessed with funnel plots and Egger’s tests.
Data collection and presentation
Two authors (RM and ST) independently selected the studies and extracted the data. In case 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, journal name, type of study, follow-up period after the diagnosis of malignant GCTB, follow-up period after the diagnosis of GCTB (in the case of secondary malignant GCTB), total number of patients with malignant GCTB; (2) number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; (3) number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths; (4) average age at diagnosis of malignant GCTB, site of malignant GCTB, Campanacci stage of malignant GCTB [11], surgical margins for malignant GCTB, pathological diagnosis of malignant GCTB, surgery or radiotherapy for the primary lesion (benign GCTB) in the case of secondary malignant GCTB, time to malignant transformation in cases of secondary malignant GCTB, and chemotherapy regimens.

英語
Literature search and study selection
Pubmed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were used to search the literature according to a systematic search strategy on 28 July 2021. In addition, the bibliographies of the retrieved literatures were used to identify other relevant studies. Publication bias was assessed with funnel plots and Egger's tests.
Data collection and presentation
Two authors (RM and ST) independently selected the studies and extracted the data. In case 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, journal name, type of study, follow-up period after the diagnosis of malignant GCTB, follow-up period after the diagnosis of GCTB (in the case of secondary malignant GCTB), total number of patients with malignant GCTB; (2) number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; (3) number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths; (4) average age at diagnosis of malignant GCTB, site of malignant GCTB, Campanacci stage of malignant GCTB [11], surgical margins for malignant GCTB, pathological diagnosis of malignant GCTB, surgery or radiotherapy for the primary lesion (benign GCTB) in the case of secondary malignant GCTB, time to malignant transformation in cases of secondary malignant GCTB, and chemotherapy regimens.

登録日時/Registered date

2021

年

08

月

02

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=R000051450

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051450