UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055550 |
|---|---|
| Receipt number | R000063483 |
| Scientific Title | Nab-paclitaxel or paclitaxel for relapsed small cell lung cancer: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2024/09/19 21:46:29 |
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Basic information
Public title
Nab-paclitaxel or paclitaxel for relapsed small cell lung cancer: a systematic review and meta-analysis
Acronym
Nab-paclitaxel or paclitaxel for relapsed small cell lung cancer: a systematic review and meta-analysis
Scientific Title
Nab-paclitaxel or paclitaxel for relapsed small cell lung cancer: a systematic review and meta-analysis
Scientific Title:Acronym
Nab-paclitaxel or paclitaxel for relapsed small cell lung cancer: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Relapsed small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A systematic review and meta-analysis of nab-paclitaxel or paclitaxel for patients with relapsed small cell lung cancer (SCLC)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to evaluate the efficacy and the safety of nab-paclitaxel or paclitaxel monotherapy as 2nd line or later treatment for extensive stage SCLC. 3-month progression survival rate, 6-month overall survival rate, objective response rate and disease control rate will be evaluated.
Key secondary outcomes
As the additional analysis, the frequency of adverse events of nab-paclitaxel or paclitaxel such as the occurrence rate of neuropathy, drug-induced pneumonia, neutropenia, anemia, thrombocytopenia and any G5 adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Clinical trials, cohort studies or retrospective observational studies evaluating the efficacy and/or safety of nab-paclitaxel or paclitaxel in patients with SCLC.
(2) Studies evaluate patients with relapsed SCLC (second-line treatment or later).
(3) Full-text papers
Key exclusion criteria
(1) Systematic review or meta-analysis papers.
(2) Case series with less than 5 patients
(3) Patients who used the regimen of carboplatin, nab-paclitaxel, or carboplatin, paclitaxel.
(4) Clinical studies which do not evaluate neither the efficacy nor the safety of nab-paclitaxel or paclitaxel.
(5) Papers not written in English.
(6) Conference abstracts
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Sousuke |
| Middle name | |
| Last name | Kubo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
2360004
Address
3-9 Kanazawa-ku, Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan
TEL
0457872800
kubo.sos.ii@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sousuke |
| Middle name | |
| Last name | Kubo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
2360004
Address
3-9 Kanazawa-ku, Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan
TEL
0457872800
Homepage URL
kubo.sos.ii@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Yokohama City University Graduate School of Medicine
Address
3-9 Kanazawa-ku, Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan
Tel
0457872800
kubo.sos.ii@yokohama-cu.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
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in September 2024. A hand search will be conducted by two investigators.
RCTs that meet the following criteria will be considered for inclusion.
Participants: Relapsed small cell lung cancer.
Intervention: Nab-paclitaxel or paclitaxel as 2nd line or later treatment.
Comparison: no control arm is set.
Outcomes: 3-month progression survival rate, 6-month overall survival rate, objective response rate and disease control rate.
Two investigators independently will screen all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Risk of bias for each study will be assessed with the Cochrane risk of bias (RoB) tool.
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063483
