UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038826 |
|---|---|
| Receipt number | R000044274 |
| Scientific Title | Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2021/12/10 09:49:26 |
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Basic information
Public title
Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review
Acronym
Lung metastases from GCTB: A systematic review
Scientific Title
Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review
Scientific Title:Acronym
Lung metastases from GCTB: A systematic review
Region
| Japan | Europe |
Condition
Condition
Lung metastases from giant cell tumor of bone
Classification by specialty
| Chest surgery | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are going to perform a systematic review of comparative studies to determine whether metastasectomy can decrease the tumor-related death in patients with operable lung metastasis from GCTB compared with non-metastasectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We counted only tumor-related death as the outcome, and excluded the death unrelated to disease and the death related to chemotherapy.
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
All comparative reports examining tumor-related death in patients who had giant cell tumors of bone and operable lung metastases and were treated with metastasectomy and non-metastasectomy, were included. Metastasectomy group included patients treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy.Non-metastasectomy group included patients treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy.We included human studies and articles with clearly-described death following treatment for lung metastases. We counted only tumor-related death, and excluded the death unrelated to disease and the death related to chemotherapy.
Key exclusion criteria
The patients who had inoperable lung metastases and were treated with observation, chemotherapy, or radiotherapy, were excluded.We excluded studies without a comparison group, those without a report of tumor-related death, isolated case reports or case series including fewer than five patients and non-English and non-Japanese language abstracts. We did not place any restrictions on the date of publication.
Target sample size
100
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
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
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
| 2019 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Orthopedics 2021
Publication of results
Published
Result
URL related to results and publications
Orthopedics 2021
Number of participants that the trial has enrolled
138
Results
The mortality of the patients was similar
in the metastasectomy and the nonmetastasectomy groups; the proportion
of patients in the metastasectomy group
who died of disease was 7.1% (6 of 85)
compared with 17.0% (9 of 53) in the
non-metastasectomy group; the overall
pooled OR was 0.64 (95% CI, 0.24-1.68;
P=.360), and the heterogeneity I2 was 0%
(Figure A, available in the online version
of the article).
Results date posted
| 2021 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 10 | Day |
Other
Other related information
Two authors (ST and AK) independently selected the studies and extracted the data. In cases 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, name of publishing journal, type of study, and total number of patients, and the length of follow-up; (2) number of patients in the metastasectomy and the non-metastasectomy groups, and proportions of patients with tumor-related death in the metastasectomy and the non-metastasectomy groups; the each total number and tumor-related death number of patients who were treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy in the metastasectomy group; the each total number and tumor-related death number of patients who were treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy in the non-metastasectomy group; (3) characteristics of the metastasectomy and the non-metastasectomy groups such as interval to lung metastases, number and extent of the lung lesions (solitary or multiple lesion, unilateral or bilateral lesion), and tendency to increase of the lung lesion (progression, stable or regression); (4) resection status (complete or incomplete resection) in the metastasectomy group; the chemotherapy regimen.
Management information
Registered date
| 2019 | Year | 12 | Month | 09 | 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=R000044274
