UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042788 |
|---|---|
| Receipt number | R000048838 |
| Scientific Title | Clinical outcomes of medical treatments for progressive desmoid tumors following active surveillance: A systematic review |
| Date of disclosure of the study information | 2020/12/18 |
| Last modified on | 2022/03/07 15:04:49 |
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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
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
sh104@naramed-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048838
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