UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcomes of medical treatments for progressive desmoid tumors following active surveillance: A systematic review
Acronym	Clinical outcomes of medical treatments for progressive desmoid tumors following active surveillance: A systematic review
Scientific Title	Clinical outcomes of medical treatments for progressive desmoid tumors following active surveillance: A systematic review
Scientific Title:Acronym	Clinical outcomes of medical treatments for progressive desmoid tumors following active surveillance: A systematic review
Region	Japan

Condition
Condition	desmoid tumor
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this systematic review was to evaluate the effectiveness and toxicity of each TKI or low-dose or conventional chemotherapeutic agents by reviewing only the studies that required progressive disease as the inclusion criterion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival, reduction of tumor size by the modified Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), disease control rate, and adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE; version 5.0).
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	We included all reports examining effectiveness and toxicity of TKIs such as imatinib, sorafenib, anlotinib, pazopanib or nilotinib or low-dose or conventional chemotherapeutic agents such as methotrexate (MTX) plus vinblastine (VBL) or vinorelbine (VNL), anthracycline based regimens, or pegylated liposomal doxorubicin for progressive DT. We included studies involving human subjects and articles that used clearly defined disease control rates or progression-free survival as an outcome. Only the articles published from January 1, 1995 in English were included.
Key exclusion criteria	We excluded studies with unclear indication of outcomes, review articles, isolated case reports or case series including fewer than five patients, non-English abstracts, and conference abstracts. We excluded studies that did not specify progressive disease as the inclusion criterion or those that reported effectiveness and toxicity of antihormonal therapies or NSAIDs.
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	0744223051
Email	shinji104@mail.goo.ne.jp

Public contact
Name of contact person	1st name Shinji Middle name Tsukamoto 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	sh104@naramed-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Nara Medical University
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, 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	0744223051
Email	ino_rinri@naramed-u.ac.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	2020 Year 12 Month 18 Day

Related information
URL releasing protocol	DOI: 10.1007/s12306-022-00738-x
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
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	2020 Year 12 Month 18 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 12 Month 18 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We search EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials (CENTRAL).The studies were classified into five modalities including low-dose chemotherapy, imatinib, TKIs except for imatinib, doxorubicin (DOX)-based, and liposomal DOX, and the other chemotherapeutic agents. We used a data collection sheet to collect the following data: (1) authors, year of publication, type of study, number of patients, intervention, interval of intervention, inclusion criteria, ratio of intraabdominal DT, ratio of primary DT, and length of follow-up; (2) progression-free survival, reduction of tumor size by the modified Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), disease control rate, and adverse events evaluated by Common Terminology Criteria for Adverse Events (CTCAE; version 5.0). We independently graded the nonrandomized studies selected for the final analysis according to the Risk of Bias Assessment tool for Nonrandomized Studies (RoBANS tool) and randomized studies according to risk of bias (RoB1 tool) in order to assess the quality of studies in meta-analyses.

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2022 Year 03 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048838