UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mortality, local recurrence, distant metastasis, and secondary malignancy incidence
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 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.
Key exclusion criteria	(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.
Target sample size	291

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	sh104@naramed-u.ac.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	sh104@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Other
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	0744-22-3051
Email	sh104@naramed-u.ac.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	2021 Year 12 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	2021 Year 12 Month 06 Day
Date of IRB	2021 Year 12 Month 06 Day
Anticipated trial start date	2021 Year 12 Month 06 Day
Last follow-up date	2021 Year 12 Month 12 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

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.).

Management information
Registered date	2021 Year 12 Month 06 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=R000052824