UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045042 |
|---|---|
| Receipt number | R000051450 |
| Scientific Title | Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2021/12/10 09:52:47 |
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Basic information
Public title
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review
Acronym
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review
Scientific Title
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review
Scientific Title:Acronym
Effect of adjuvant chemotherapy on localized malignant giant cell tumor of bone: a systematic review
Region
| Japan | Europe |
Condition
Condition
malignant giant cell tumor of bone
Classification by specialty
| Hematology and clinical oncology | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of adjuvant chemotherapy for localized malignant GCTB, we performed a systematic review of studies comparing mortality in patients who underwent wide resection or wide resection plus adjuvant chemotherapy for primary and secondary localized malignant GCTB respectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths;
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
Patients who underwent surgery alone for the primary tumor of malignant GCTB and chemotherapy for distant metastases that occurred during the course of the disease were classified as the surgery alone group. Regarding the number of deaths, only deaths due to tumor were counted. Only literatures written in English and Japanese were included, and no restrictions were placed on the year of publication.
Key exclusion criteria
Patients with distant metastasis at the time of diagnosis of malignant GCTB were excluded. Patients with an unclear prognosis were also 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
+81-744-22-3051
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
+81-744-22-3051
Homepage URL
sh104@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 08 | Month | 02 | Day |
Related information
URL releasing protocol
doi.org/10.3390/cancers13215410
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
112
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 | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Literature search and study selection
Pubmed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were used to search the literature according to a systematic search strategy on 28 July 2021. 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.
Data collection and presentation
Two authors (RM and ST) independently selected the studies and extracted the data. In case of disagreement, a consensus was either achieved between them or by consulting a third author. A data collection sheet was used to collate the following data: (1) basic data: authors, year of publication, journal name, type of study, follow-up period after the diagnosis of malignant GCTB, follow-up period after the diagnosis of GCTB (in the case of secondary malignant GCTB), total number of patients with malignant GCTB; (2) number of patients treated with surgery and adjuvant chemotherapy for primary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for primary malignant GCTB and number of tumor-related deaths; (3) number of patients treated with surgery and adjuvant chemotherapy for secondary malignant GCTB and number of tumor-related deaths, number of patients who underwent surgery alone for secondary malignant GCTB and number of tumor-related deaths; (4) average age at diagnosis of malignant GCTB, site of malignant GCTB, Campanacci stage of malignant GCTB [11], surgical margins for malignant GCTB, pathological diagnosis of malignant GCTB, surgery or radiotherapy for the primary lesion (benign GCTB) in the case of secondary malignant GCTB, time to malignant transformation in cases of secondary malignant GCTB, and chemotherapy regimens.
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051450
