UMIN-CTR Clinical Trial

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
Email	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
Email	shinji104@mail.goo.ne.jp

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044274