UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047442 |
|---|---|
| Receipt number | R000054100 |
| Scientific Title | Effect of adjuvant chemotherapy on extraskeletal osteosarcoma: a systematic review |
| Date of disclosure of the study information | 2022/04/08 |
| Last modified on | 2022/06/06 10:35:08 |
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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
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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054100
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