UMIN-ICDS Clinical Trial

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

dedifferentiated chondrosarcoma

Classification by specialty

Hematology and clinical oncology

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

5-year survival rate

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Email

shinji104@mail.goo.ne.jp

Institute

Nara Medical University

Institute

Department

Personal name

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nara Medical University

Address

840, Shijo-cho, Kashihara-city Nara 634-8521, Japan

Tel

0744223051

Email

shinji104@mail.goo.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

10

Day

Date of IRB

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 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.

Registered date

2023

Year

11

Month

10

Day

Last modified on

2023

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060209