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 2019/09/04 19:46:55

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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 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

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

Value
https://center6.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