UMIN-CTR Clinical Trial

Basic information
Public title	Effect of adjuvant chemotherapy on extraskeletal osteosarcoma: a systematic review
Acronym	Effect of adjuvant chemotherapy on extraskeletal osteosarcoma: a systematic review
Scientific Title	Effect of adjuvant chemotherapy on extraskeletal osteosarcoma: a systematic review
Scientific Title:Acronym	Effect of adjuvant chemotherapy on extraskeletal osteosarcoma: a systematic review
Region	Japan Europe

Condition
Condition	extraskeletal osteosarcoma
Classification by specialty	Hematology and clinical oncology Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of (neo-)adjuvant chemotherapy for localized ESOS, we performed a systematic review of studies comparing 5-year disease-free survival rate between patients who received surgery combined with (neo-)adjuvant chemotherapy and patients who received surgery alone.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year disease-free survival rate
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We included only studies reporting 5-year disease-free survival rate after surgery alone or surgery and (neo-)adjuvant chemotherapy for localized ESOS.
Key exclusion criteria	(1) We excluded patients with distant metastases at presentation. We excluded studies that did not specify 5-year disease-free survival rate, did not have a control group, or had fewer than five patients in total. (2) Patients who underwent surgery alone for localized ESOS and received chemotherapy for distant metastases that developed during the course of the disease were classified into the surgery alone group. (3) Only literature in English, Italian, and Japanese was included, and the year of publication was not restricted. Only human studies were included and animal studies were excluded.
Target sample size

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Tsukamoto
Organization	Nara Medical University
Division name	Department of Orthopaedic Surgery
Zip code	634-8521
Address	840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL	0744-22-3051
Email	shinji104@mail.goo.ne.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Tsukamoto
Organization	Nara Medical University
Division name	Department of Orthopaedic Surgery
Zip code	634-8521
Address	840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL	0744-22-3051
Homepage URL
Email	shinji104@mail.goo.ne.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University
Address	840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
Tel	0744223051
Email	shinji104@mail.goo.ne.jp

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

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	761
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	Completed
Date of protocol fixation	2022 Year 04 Month 08 Day
Date of IRB	2022 Year 04 Month 08 Day
Anticipated trial start date	2022 Year 04 Month 08 Day
Last follow-up date	2022 Year 04 Month 13 Day
Date of closure to data entry	2022 Year 06 Month 06 Day
Date trial data considered complete	2022 Year 06 Month 06 Day
Date analysis concluded	2022 Year 06 Month 06 Day

Other

Other related information

Data collection and presentation Two authors (ST and LA) independently selected studies and extracted data. In case of disagreement, agreement was reached between the two or the third author was consulted. The following data were collected using the data collection sheet. (1) basic data: author, year of publication, type of study, follow-up period since diagnosis of ESOS, number of patients with localized ESOS. (2) Number of patients who underwent surgery and (neo-) adjuvant chemotherapy for localized ESOS and the number of patients who survived disease-free for 5 years of them. Number of patients who underwent surgery alone for localized ESOS and the number of patients who survived disease-free for 5 years of them. (3) Ratio of male/female patients, age, tumor site, tumor size, surgical margin, adjuvant radiotherapy, and histological grade in the surgery plus (neo-)adjuvant chemotherapy group and the surgery alone group, respectively. (4) Chemotherapy regimen, histologic evidence of necrosis following preoperative chemotherapy. Data summary, synthesis, and meta-analysis Data extracted from the collected study data were summarized (Tables 1 and 2). The dataset includes the name of the first author, year of publication, number of patients who underwent surgery and (neo-)adjuvant chemotherapy for localized ESOS and the number of patients who survived 5 years disease-free of them, number of patients who underwent surgery only for localized ESOS and the number of patients who survived 5 years disease-free of them. Random effects models were used to estimate odds ratios to compare 5-year disease-free survival rate between surgery plus (neo-) adjuvant chemotherapy and surgery alone groups. 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.).

Management information
Registered date	2022 Year 04 Month 08 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054100