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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008130
Receipt No. R000009557
Scientific Title Feasibility study of the combination of cisplatin and docetaxel with concurrent thoracic radiotherapy for locally advanced resectable non-small cell lung cancer.
Date of disclosure of the study information 2012/06/10
Last modified on 2012/06/09

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Basic information
Public title Feasibility study of the combination of cisplatin and docetaxel with concurrent thoracic radiotherapy for locally advanced resectable non-small cell lung cancer.
Acronym Feasibility study of the combination of cisplatin and docetaxel with concurrent thoracic radiotherapy for locally advanced resectable non-small cell lung cancer.
Scientific Title Feasibility study of the combination of cisplatin and docetaxel with concurrent thoracic radiotherapy for locally advanced resectable non-small cell lung cancer.
Scientific Title:Acronym Feasibility study of the combination of cisplatin and docetaxel with concurrent thoracic radiotherapy for locally advanced resectable non-small cell lung cancer.
Region
Japan

Condition
Condition Locally advanced resectable non-small-cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The effectiveness and safety of concullent irradiation combined with cisplatin and docetaxel for unresectablr NSCLC has been shown by OLCSG0007 trial.
In the current study, to verify the safety of preoperative induction therapy as cisplatin and docetaxel with concurrent irradiation of 45Gy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment compliance
Safety
Feasibility
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination chemotherapy of cisplatin and docetaxel with concurrent thoracic radiation therapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Histologically or cytologically confirmed non-small-cell lung cancer
No prior therapy
Age: 75 years or less
Disease stage of resectable IIIA
ECOG performance status of 0 or 1
Measurable lesion(s)
Adequate bone marrow function
WBC 4,000/cmm or more; PLT 100,000/cmm or more
Adequate liver function
T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution
Adequate kidney function
Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more
Adequate pulmonary function
Pa02 60 Torr or more
However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement.
Acquisition of written informed consent
Key exclusion criteria Presence of malignant pleural effusion or malignant pericardial fluid
Presence of pleural dissemination
Presence of active double cancers
Even in the case of asynchronous double cancers, the patient will be excluded if there is a past history of chemotherapy or thoracic radiotherapy.

Presence of serious complications
1)Interstitial pneumonia
2)Serious heart disease (e.g., difficult to control angina pectoris, myocardial infarction within the past 3 months, etc.)
3)Difficult to control diabetes mellitus
4)Serious infection
5)Presence of any other complications which can be thought to represent a serious impediment to performance of the therapy

Pregnancy, breast feeding or the intention to become pregnant
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhito Funai
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2276
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization 1-20-1, Handayama, Higashi-ku, Hamamatsu
Division name First Department of Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2012 Year 06 Month 10 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
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 Open public recruiting
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 09 Day
Last modified on
2012 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009557

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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