UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008130 |
|---|---|
| Receipt number | 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 | 2023/06/21 17:36:14 |
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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 | Funai |
| Middle name | |
| Last name | Kazuhito |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2276
funai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhito |
| Middle name | |
| Last name | Funai |
Organization
1-20-1, Handayama, Higashi-ku, Hamamatsu
Division name
First Department of Surgery
Zip code
4313192
Address
1-20-1, Handa-yama, Higashi-ku, Hamamatsu
TEL
0534352276
Homepage URL
funai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
Tel
0534352276
rinri@hama0.-med.ac.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
| 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
3
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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2012 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009557
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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