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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028952
Receipt No. 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 2019/09/04

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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
Email 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
Email chuang@kitano-hp.or.jp

Sponsor
Institute Dapartment of Thoracic Surgery, Kitano hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
2031 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 01 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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