UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046286 |
|---|---|
| Receipt number | R000052824 |
| Scientific Title | Effect of adjuvant chemotherapy on periosteal osteosarcoma: a systematic review |
| Date of disclosure of the study information | 2021/12/06 |
| Last modified on | 2022/06/06 10:31:06 |
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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
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
sh104@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052824
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