UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028952 |
|---|---|
| Receipt number | R000033128 |
| Scientific Title | Tailor-made chemotherapy based on biomarker for lung cancer and malignant mediastinal tumor |
| Date of disclosure of the study information | 2017/09/02 |
| Last modified on | 2025/03/10 08:47:54 |
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Basic information
Public title
Tailor-made chemotherapy based on biomarker for lung cancer and malignant mediastinal tumor
Acronym
Tailor-made chemotherapy based on biomarker
Scientific Title
Tailor-made chemotherapy based on biomarker for lung cancer and malignant mediastinal tumor
Scientific Title:Acronym
Tailor-made chemotherapy based on biomarker
Region
| Japan |
Condition
Condition
lung cancer, malignant mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of chemotherapy-associated biomarkers in tumors for effective tailor-made chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival rate at 3 years after initial treatment
Key secondary outcomes
progression-free survival rate at 3 years after initial treatment
response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tailor-made chemothrapy is performed for patients with advanced-stage cancer or reccurent tumor after surgery. The tailor-made chemothrapy is contined until detection of re-growth of tumors.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
advanced stage lung cancer
advanced stage malignant mediastinal tumor
Key exclusion criteria
Patients not applicable for conventinal chemotherapy, due to leukocytopenia, thrombocytopenia, hepatic dysfunction, or renal dysfunction.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Cheng-long |
| Middle name | |
| Last name | Huang |
Organization
Kitano hospital
Division name
Department of Thoracic Surgery
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL
06-6312-1221
chuang@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Cheng-long |
| Middle name | |
| Last name | Huang |
Organization
Kitano hospital
Division name
Department of Thoracic Surgery
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
TEL
06-6312-1221
Homepage URL
http://www.kitano-hp.or.jp/etcproject/kokyuki-center/kenkyu_kokyuki-center/index.html
chuang@kitano-hp.or.jp
Sponsor or person
Institute
Dapartment of Thoracic Surgery, Kitano hospital
Institute
Department
Personal name
Funding Source
Organization
Kitano hospital
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
Kitano Hospital
Address
2-4-20 Ohgimachi, Kita-Ku, Osaka
Tel
06-6312-1221
chuang@kitano-hp.or.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
| 2017 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
http://www.kitano-hp.or.jp/etcproject/kokyuki-center/kenkyu_kokyuki-center/index.html
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The reccurence-free survival rate was significantly higher in patients with class III-beta tubulin-low tumors and treated with taxane for postoperative adjuvant chemotherapy. Evaluation of intratumoral expression of class III-beta tubulin is usuful for selection of postoperative adjuvant chemotherapy(The 34th annual meeting of the Japanese-association for chest surgery, Fukuoka 2017.5.18.).
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
| 2011 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033128
