UMIN-CTR Clinical Trial

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
Email	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
Email	sh104@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051450