UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040729 |
|---|---|
| Receipt number | R000046499 |
| Scientific Title | Postoperative Radiotherapy for completely resected stage II/III thymoma |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2021/12/20 12:31:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Postoperative Radiotherapy for completely resected stage II/III thymoma
Acronym
Postoperative Radiotherapy for completely resected stage II/III thymoma
Scientific Title
Postoperative Radiotherapy for completely resected stage II/III thymoma
Scientific Title:Acronym
Postoperative Radiotherapy for completely resected stage II/III thymoma
Region
| Japan |
Condition
Condition
thymoma
Classification by specialty
| Chest surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Thymoma is a rare disease affecting between 100,000 to 0.44 and 0.68 of the population. Thymoma is essentially asymptomatic unless the tumor invades the surrounding tissues, but complications such as myasthenia gravis, erythroblastical taberculosis, and hypogammaglobulinemia may occur. Resection is the standard treatment for thymoma of the Masaoka-Koga clinical stage II and III.
In addition, depending on the stage of the disease, postoperative radiation therapy (PORT) may be used. PORT is recommended for pathological cancer remnants (R1), chemotherapy and PORT is recommended for gross cancer remnants (R2). PORT may be added in some cases even in complete resection cases (R0). An analysis of 870 completely resected stage II thymoma cases in the International Thymic Malignancy Interest Group (ITMIG) database showed an improvement in survival with PORT. A propensity score analysis of 2,030 patients enrolled in European Society of Thoracic Surgeons (ESTS) between 1990 and 2010 reported that PORT contributed to overall survival. On the other hand, a large case study in Japan showed no improvement in survival or prolonged progression-free period in stage II and III thymoma. Thus, various opinions exist on the need for PORT, and there is no clear guidance on treatment strategies in the guidelines. A previous meta-analysis on this topic has been reported, but it has not yet been adopted in the guidelines, probably because of the paucity of papers comparing each stage in isolation. In addition, a systematic review of 22 retrospective cohort studies found no reduction in recurrence with radiotherapy. Four years have passed since the previous study and reports of new clinical studies are accepted. It is hoped that this study will lead to a more established position of PORT in stage II and III thymoma, where there is a lack of consensus of opinion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hazard ratio of overall survival
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
Study selection, study design
We will include an RCT and an observational study that compared surgery alone versus surgery plus postoperative radiation for stage II and III thymoma. A propensity score matched case-control study will be allowed. When an article evaluated stage I or IV patients along with stage II/III patient, the data for stage II/III subgroup should be extractable. An article will have to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded.
Study selection, patient
Patients with a pathologic or cytologic confirmed diagnosis of stage II and III thymoma will be included.
Study selection, treatment
The operation for stage II/III thymoma should be designed to completely resect the disease regardless of surgical procedure. Postoperative irradiation with any delivery method and radiation dosage will be allowed.
Key exclusion criteria
not applicable
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama city university graduate school of medicine
Division name
Department of pulmonology
Zip code
235-0004
Address
3-9 Fukuura,Kanazawa ku,Yokohama city,Japan
TEL
045-787-2800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama city university graduate school of medicine
Division name
Department of pulmonology
Zip code
235-0004
Address
3-9 Fukuura,Kanazawa ku,Yokohama city,Japan
TEL
045-787-2800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university graduate school of medicine
Institute
Department
Personal name
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
045-787-2800
horitano@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
| 2020 | Year | 06 | Month | 12 | 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
4746
Results
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Results date posted
| 2021 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Date of the first journal publication of results
Baseline Characteristics
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Participant flow
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Adverse events
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Outcome measures
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Plan to share IPD
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
IPD sharing Plan description
Please see:
J Thorac Oncol. 2021 Apr;16(4):677-685. doi: 10.1016/j.jtho.2020.12.023.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Search
We will systematically search PubMed, the Cochrane database, EMBASE, and Web of Science as of June 12, 2020. The search strategy for PubMed will be as follows:
#1 (postoperative or post-operative or postoperation or post-operation or post-surgery or removal or removed or operation or operative or surgery or surgical or resection or resected or adjuvant) and (radiotherapy or radiation or irradiation)
#2 (thymoma[title] or thymic tumor [title] or thymic epithelial tumor[title]) and (postoperative[title] or post-operative[title] or postoperation[title] or post-operation[title] or post-surgery[title] or removal[title] or removed[title] or operation[title] or operative[title] or surgery[title] or surgical[title] or resection[title] or resected[title] or adjuvant[title] or radiotherapy[title] or radiation[title] or irradiation[title])
#1 and #2.
Reference lists in the included articles and review articles will be also hand searched.
Data synthesis
HR from a randomized controlled trial and propensity score matched study will be pooled. Adjusted HR from a prospective or a retrospective cohort study will be also used. Prior to generic inverse variance meta-analysis using RevMan 5.0 (Cochrane Collaboration, London, UK), HR will be log converted.
Subgroup analyses will focus on stage II and stage III patents will be performed. To facilitate stage-based subgroup analysis, data specific for stage II and III thymoma will be preferred for the main analysis.
Statistical significance will be judged by P < 0.05.
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046499
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
