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
Effect of adjuvant chemotherapy on periosteal osteosarcoma: a systematic review

英語
Effect of adjuvant chemotherapy on periosteal osteosarcoma: a systematic review

一般向け試験名略称/Acronym

日本語
Chemotherapy for periosteal osteosarcoma

英語
Chemotherapy for periosteal osteosarcoma

科学的試験名/Scientific Title

日本語
Effect of adjuvant chemotherapy on periosteal osteosarcoma: a systematic review

英語
Effect of adjuvant chemotherapy on periosteal osteosarcoma: a systematic review

科学的試験名略称/Scientific Title:Acronym

日本語
Chemotherapy for periosteal osteosarcoma

英語
Chemotherapy for periosteal osteosarcoma

試験実施地域/Region

日本/Japan	欧州/Europe

対象疾患名/Condition

日本語
periosteal osteosarcoma

英語
periosteal osteosarcoma

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
We conducted a systematic review of studies comparing mortality, local recurrence, distant metastasis, and secondary malignancy incidence among patients who received surgery and (neo-) adjuvant chemotherapy or surgery alone for periosteal osteosarcoma without distant metastases at diagnosis in order to investigate the effect and toxicity (development of secondary malignancy) of (neo-) adjuvant chemotherapy.

英語
We conducted a systematic review of studies comparing mortality, local recurrence, distant metastasis, and secondary malignancy incidence among patients who received surgery and (neo-) adjuvant chemotherapy or surgery alone for periosteal osteosarcoma without distant metastases at diagnosis in order to investigate the effect and toxicity (development of secondary malignancy) of (neo-) adjuvant chemotherapy.

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
mortality, local recurrence, distant metastasis, and secondary malignancy incidence

英語
mortality, local recurrence, distant metastasis, and secondary malignancy incidence

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
We included the only studies that performed surgery and (neo-) adjuvant chemotherapy or surgery alone for patients who had periosteal osteosarcoma without distant metastases at diagnosis and reported prognosis or the development of secondary malignancy.

英語
We included the only studies that performed surgery and (neo-) adjuvant chemotherapy or surgery alone for patients who had periosteal osteosarcoma without distant metastases at diagnosis and reported prognosis or the development of secondary malignancy.

除外基準/Key exclusion criteria

日本語
(1) Patients with periosteal osteosarcoma and distant metastases at the diagnosis were excluded. Patients with no data regarding the prognosis were also excluded. (2) Patients with periosteal osteosarcoma who underwent surgery alone and palliative chemotherapy for distant metastases that occurred during the follow up were classified into the surgery alone group. (3) Regarding the number of deaths, only tumor-related deaths were counted. We also analyzed the risk of local recurrence, distant metastasis, and secondary malignancy. (4) There were no restrictions on the year of publication, targeting only English and Japanese literature.

英語
(1) Patients with periosteal osteosarcoma and distant metastases at the diagnosis were excluded. Patients with no data regarding the prognosis were also excluded. (2) Patients with periosteal osteosarcoma who underwent surgery alone and palliative chemotherapy for distant metastases that occurred during the follow up were classified into the surgery alone group. (3) Regarding the number of deaths, only tumor-related deaths were counted. We also analyzed the risk of local recurrence, distant metastasis, and secondary malignancy. (4) There were no restrictions on the year of publication, targeting only English and Japanese literature.

目標参加者数/Target sample size

291

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

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

0744-22-3051

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

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

機関名/Organization
（機関選択不可の場合）

日本語

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
Nara Medical University

英語
Nara Medical University

住所/Address

日本語
840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan

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

電話/Tel

0744-22-3051

Email/Email

sh104@naramed-u.ac.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

2021

年

12

月

06

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

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

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

12

月

06

日

倫理委員会による承認日/Date of IRB

2021

年

12

月

06

日

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

2021

年

12

月

06

日

フォロー終了(予定)日/Last follow-up date

2021

年

12

月

12

日

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

2022

年

06

月

06

日

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

2022

年

06

月

06

日

解析終了(予定)日/Date analysis concluded

2022

年

06

月

06

日

その他関連情報/Other related information

日本語
The literature was searched on November 12, 2021 according to a systematic search strategy using Pubmed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases (Supplementary Material). 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. Two authors (ST and AK) independently selected studies and extracted data. If there was a disagreement, we consulted with a third author to reach an agreement between the two. The following data were collected using the data collection sheet. (1) Basic data: author, year of publication, journal name, type of study, follow-up period after a diagnosis of PO, number of patients with PO (2) The number of patients with PO who underwent surgery alone or surgery and (neo-) adjuvant chemotherapy, and the number of patients who had tumor-related death, local recurrence, distant metastasis, or secondary malignancy. (3) Male-female ratio, age, tumor site, tumor size, medullary involvement, surgical margin, histological grade [8], in surgery and (neo-) adjuvant chemotherapy group and surgery alone group, respectively. (4) Chemotherapy regimen, histologic evidence of necrosis following preoperative chemotherapy which was determined according to the grading system described by Huvos [9]. Odds ratios for comparing the ratio of tumor-related death, local recurrence, distant metastasis, and secondary malignancy incidence between the surgery and (neo-) adjuvant chemotherapy group and surgery alone group, were estimated using a random effect model. The extent of heterogeneity between studies was evaluated using the inconsistency statistic (I2). All statistical analyses were performed assuming a two-sided test at a 5% level of significance using ProMeta software, version 3 (INTERNOVI di Scarpellini Daniele s.a.s.).

英語
The literature was searched on November 12, 2021 according to a systematic search strategy using Pubmed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases (Supplementary Material). 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. Two authors (ST and AK) independently selected studies and extracted data. If there was a disagreement, we consulted with a third author to reach an agreement between the two. The following data were collected using the data collection sheet.(1) Basic data: author, year of publication, journal name, type of study, follow-up period after a diagnosis of PO, number of patients with PO (2) The number of patients with PO who underwent surgery alone or surgery and (neo-) adjuvant chemotherapy, and the number of patients who had tumor-related death, local recurrence, distant metastasis, or secondary malignancy. (3) Male-female ratio, age, tumor site, tumor size, medullary involvement, surgical margin, histological grade [8], in surgery and (neo-) adjuvant chemotherapy group and surgery alone group, respectively. (4) Chemotherapy regimen, histologic evidence of necrosis following preoperative chemotherapy which was determined according to the grading system described by Huvos [9]. Odds ratios for comparing the ratio of tumor-related death, local recurrence, distant metastasis, and secondary malignancy incidence between the surgery and (neo-) adjuvant chemotherapy group and surgery alone group, were estimated using a random effect model. The extent of heterogeneity between studies was evaluated using the inconsistency statistic (I2). All statistical analyses were performed assuming a two-sided test at a 5% level of significance using ProMeta software, version 3 (INTERNOVI di Scarpellini Daniele s.a.s.).

登録日時/Registered date

2021

年

12

月

06

日

最終更新日/Last modified on

2022

年

06

月

06

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=R000052824

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052824