UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052763 |
|---|---|
| Receipt number | R000060209 |
| Scientific Title | Effect of adjuvant chemotherapy on localized dedifferentiated chondrosarcoma: a systematic review |
| Date of disclosure of the study information | 2023/11/10 |
| Last modified on | 2024/05/13 10:10:21 |
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Basic information
Public title
Effect of adjuvant chemotherapy on localized dedifferentiated chondrosarcoma: a systematic review
Acronym
Effect of adjuvant chemotherapy on localized dedifferentiated chondrosarcoma: a systematic review
Scientific Title
Effect of adjuvant chemotherapy on localized dedifferentiated chondrosarcoma: a systematic review
Scientific Title:Acronym
Effect of adjuvant chemotherapy on localized dedifferentiated chondrosarcoma: a systematic review
Region
| Japan | Europe |
Condition
Condition
dedifferentiated chondrosarcoma
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 DDCS, we performed a systematic review of studies that compared the 5-year survival rate among patients who received surgery plus (neo-)adjuvant chemotherapy or surgery alone for localized DDCS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year 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
Only studies reporting 5-year survival rates after surgery and (neo-)adjuvant chemotherapy or surgery alone for localized DDCS without distant metastasis at diagnosis were included.
Key exclusion criteria
(1) Patients with distant metastases at diagnosis of DDCS were excluded. Studies that did not specify 5-year survival rates or did not have a control group were also excluded. (2) Patients who underwent surgery alone for primary DDCS and received palliative chemotherapy for distant metastases that developed during the course of the disease were classified into the surgery alone group without (neo-)adjuvant chemotherapy. (3) Only English- and Japanese-language literature was included, with no restriction on the 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
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
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
Self funding
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
| 2023 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/1718-7729/31/1/40
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1718-7729/31/1/40
Number of participants that the trial has enrolled
556
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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The literature was searched on October 26, 2023, following a systematic search strategy using Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases (Appendix 1). In addition, the bibliographies of the retrieved literatures were used to identify other relevant studies.
Two authors (ST and TM) independently selected studies and extracted data. In case of disagreement, the two authors either reached an agreement between them or consulted the third author. The following data were collected using the data collection sheet. (1) Basic data: author, year of publication, journal title, type of study, duration of study, follow-up period after diagnosis of DDCS, and number of patients with localized DDCS (2) Number of patients who received surgery and (neo-)adjuvant chemotherapy for localized DDCS and the number of those who survived 5 years of them, number of patients who received surgery alone for localized DDCS and the number of those who survived 5 years of them (3) Ratio of male to female patients, age, tumor location, tumor size, radiographic subtype (central or peripheral), pathological fracture, surgical margin, adjuvant radiotherapy, percentage of dedifferentiated areas in the surgery plus (neo-)adjuvant chemotherapy group and the surgery alone group, respectively. (4) chemotherapy regimen, histologic evidence of necrosis following neoadjuvant chemotherapy.
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | 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=R000060209
