UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048997 |
|---|---|
| Receipt number | R000055817 |
| Scientific Title | Effect of adjuvant chemotherapy on localized dedifferentiated low-grade osteosarcoma: a systematic review |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2024/05/13 10:07:39 |
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Basic information
Public title
Effect of adjuvant chemotherapy on localized dedifferentiated low-grade osteosarcoma: a systematic review
Acronym
Effect of adjuvant chemotherapy on localized dedifferentiated low-grade osteosarcoma: a systematic review
Scientific Title
Effect of adjuvant chemotherapy on localized dedifferentiated low-grade osteosarcoma: a systematic review
Scientific Title:Acronym
Effect of adjuvant chemotherapy on localized dedifferentiated low-grade osteosarcoma: a systematic review
Region
| Japan | Europe |
Condition
Condition
dedifferentiated low-grade osteosarcoma(DLOS)
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 DLOS, we performed a systematic review of studies comparing mortality and event rates, including local recurrence and distant metastasis, among patients who underwent wide resection or wide resection and (neo-)adjuvant chemotherapy for localized DLOS without distant metastasis at diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality and event rates, including local recurrence and distant metastasis
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included only studies that reported mortality and event rates, such as local recurrence and distant metastasis, after surgery alone or surgery and (neo-)adjuvant chemotherapy for localized DLOS without distant metastasis at diagnosis.
Key exclusion criteria
(1) Patients with distant metastasis at the time of DLOS diagnosis were excluded. Studies that did not specify mortality or event rates such as local recurrence or distant metastasis, or did not have a comparison group were also excluded. (2) Patients who underwent surgery alone for primary DLOS and received palliative chemotherapy for distant metastases that developed during the course of the disease were classified into the surgery-only group without adjuvant chemotherapy. (3) Only English- and Japanese-language literature was included, with no restriction on year of publication. Only human subjects were included and animals 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
0744223051
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
0744223051
Homepage URL
shinji104@mail.goo.ne.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Nara
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
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 | 09 | Month | 22 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12306-024-00821-5
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12306-024-00821-5
Number of participants that the trial has enrolled
114
Results
Mortality rates of the resection plus chemotherapy (R + C) and the resection only (Ronly) groups were 20.3% and 11.4%, respectively [overall pooled odds ratio, 1.59 (P = 0.662); heterogeneity I2, 0%]. The local recurrence or distant metastasis rate in the R + C group was 36.7% and that in the Ronly group was 28.6% [overall pooled odds ratio, 1.37 (P = 0.484); heterogeneity I2 was 0%].
Results date posted
| 2024 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We identified 712 studies through systematic searches of Embase, PubMed, and the Cochrane Central Register of Controlled Trials databases. Of those studies, seven were included in this review and none were randomized controlled trials. In the seven studies, 114 localized dedifferentiated low-grade osteosarcoma patients were examined.
Participant flow
We identified 712 studies through systematic searches of Embase, PubMed, and the Cochrane Central Register of Controlled Trials databases. Of those studies, seven were included in this review and none were randomized controlled trials. In the seven studies, 114 localized dedifferentiated low-grade osteosarcoma patients were examined.
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection and presentation
Two authors (ST and TM) independently selected studies and extracted data. In case of any 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, journal name, type of study, follow-up period since diagnosis of DLOS, number of patients with localized DLOS (2) Number of patients who underwent surgery and (neo-)adjuvant chemotherapy for localized DLOS and the number of patients who had tumor death, local recurrence or distant metastasis. Number of patients who underwent surgery only for localized DLOS and the number of patients who had tumor death, local recurrence or distant metastasis. (3) Ratio of men to women, age, tumor site, tumor size, and subtype (parosteal or low-grade central osteosarcoma) of the original low-grade osteosarcoma, timing of dedifferentiation (synchronous or metachronous), surgical margins, adjuvant radiotherapy, and percentage of dedifferentiated areas, in the surgery plus (neo-)adjuvant chemotherapy group and the surgery alone group, respectively. (4) chemotherapy regimen, histological evidence of necrosis following preoperative chemotherapy (percentage of necrosis in the entire specimen, including low-grade component).
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055817
