UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048181 |
|---|---|
| Receipt number | R000054902 |
| Scientific Title | An Observational Study of Treatment for Unresectable Masaoka Stage III/IV and Recurrent Thymoma in Real World |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2023/12/28 02:17:54 |
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Basic information
Public title
An Observational Study of Treatment for Unresectable Masaoka Stage III/IV and Recurrent Thymoma in Real World
Acronym
NEJ023B
Scientific Title
An Observational Study of Treatment for Unresectable Masaoka Stage III/IV and Recurrent Thymoma in Real World
Scientific Title:Acronym
NEJ023B
Region
| Japan |
Condition
Condition
Unresectable Masaoka III/IV stage and recurrent thymoma
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
(1) To compare cisplatin, anthracyclines and other treatment as first-line treatment for unresectable thymic epithelial tumours.
(2) To examine the outcome of anticancer chemotherapy after second-line treatment.
(3)Dosage, duration, disease control rate and response rate of steroid as anti-canser agent.
In addition, to examine whether there are differences in these for each WHO histological classification of thymoma, and other factors related to prognosis.
Basic objectives2
Others
Basic objectives -Others
Descriptive analyses will be considered for PD-L1 TPS and cancer genome profiling test results. Other analyses include overall survival, survival after initiation of chemoradiotherapy, survival after initiation of first-line chemotherapy, survival after initiation of second-line chemotherapy, survival after initiation of third-line chemotherapy, survival after initiation of fourth-line chemotherapy, overall response rate of each chemotherapy (including chemoradiotherapy), duration of treatment for each chemotherapy (including chemoradiotherapy), duration of Response rate for each chemotherapy (including chemoradiotherapy), progression-free survival for each chemotherapy (including chemoradiotherapy), survival/response rate/progression-free survival after initiation of palliative steroid therapy, disease control rate for palliative radiotherapy, and proportion of cancer genome profiling tests linked to anticancer chemotherapy (including clinical trials and trials).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
progression-free survival (PFS) and time to treatment failure
Key secondary outcomes
Overall survival, response rate, disease control rate and percentage of cancer genomic profiling tests linked to anticancer chemotherapy.
Base
Study type
Observational
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
1) Histologically diagnosed as thymoma.
2) Diagnosed between 1 April 2000 and 31 March 2020, with stage III or stage IV disease at the time of initial diagnosis and deemed unresectable. Alternatively, recurrence cases between 1 April 2000 and 31 March 2020 after curative surgery.
3) One or more of radiotherapy or anticancer chemotherapy was administered.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | takehito |
| Middle name | |
| Last name | shukuya |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1062
tshukuya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Go Saito / Ryo Ko |
| Middle name | |
| Last name | Go Saito / Ryo Ko |
Organization
Chiba University / Shizuoka Cancer Center
Division name
Department of Respirology / Division of Thoracic Oncology
Zip code
260-8677 / 411-8777
Address
1-8-1, Inohana, Chiba-shi, Chiba / 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
043-222-7171.055-989-5222
Homepage URL
gosaitoh@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1062
None
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
| 2022 | Year | 06 | Month | 27 | 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
207
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background: date of diagnosis, gender, age at diagnosis, histology, Masaoka classification, site of metastasis, PD-L1 expression in tumour tissue and antibodies measured, smoking history, presence or absence of existing lung stromal changes (and imaging pattern if any), presence or absence of concomitant tumour-associated syndrome and its name, history of thymoma resection (if any), date, perioperative radiation to the thymoma and its details, history of perioperative chemotherapy to the thymoma and its regimen. History and details of perioperative radiation to thymoma, history and regimen of perioperative chemotherapy.
Survival information: outcome, date of last known survival/death
Treatment information: names of regimens (including steroids) administered during the course of treatment, efficacy, start date/number of doses of each regimen, presence/absence of radiotherapy, site of irradiation, date of irradiation, dose/number of doses, presence/surgery/operative date of surgical treatment, starting performance status (ECOG), and Dose status at the time of creation of CRF
Cancer genome profiling test: type of specimen used for cancer genome profiling test, date/timing of collection of specimen used for cancer genome profiling test, date of cancer genome profiling test, type of cancer genome profiling test, pathogenic variant obtained (somatic cell lineage only). Tumor Mutation Burden, Microsatellite instability
Management information
Registered date
| 2022 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054902
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