UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017408 |
|---|---|
| Receipt number | R000019491 |
| Scientific Title | A prospective randomized control trial comparing systematic and selective mediastinal lymph node dissection in elderly non-small cell lung cancer patients. |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2019/08/22 16:01:29 |
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Basic information
Public title
A prospective randomized control trial comparing systematic and selective mediastinal lymph node dissection in elderly non-small cell lung cancer patients.
Acronym
A prospective RCT comparing systematic and selective mediastinal lymph node dissection in elderly NSCLC patients.
Scientific Title
A prospective randomized control trial comparing systematic and selective mediastinal lymph node dissection in elderly non-small cell lung cancer patients.
Scientific Title:Acronym
A prospective RCT comparing systematic and selective mediastinal lymph node dissection in elderly NSCLC patients.
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the superiority of selective lymph node dissection comparing with systematic lymph node dissection about postoperative complication rate in elderly patients with non-small cell lung cancer(earlier than cT2N1M0).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The rate of complications in the early postoperative period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Systematic Lymph node Dissection
Interventions/Control_2
Selective Lymph node Dissection
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First stage registration
1)Contrast-enhanced CT, positron emission tomography-CT (or bone scintigraphy) and enhanced brain MRI findings fulfill all of the following conditions.
i)resectable lung tumors.
ii)no more than cT2a and without inter-lobe PL3.
iii)no metastasis in mediastinal lymph nodes
iv)non-small cell lung carcinoma is diagnosed or suspected. Neither Carcinoid nor large-cell neuroendocrine carcinoma.
v)no distant metastasis.
2)Aged 75 or older.
3)No past history of ipsilateral thoracotomy.
4)No surgery, chemotherapy or radiation therapy for any malignant diseases in the past two years.
5)Lobectomy and systematic lymph node dissection are acceptable with following conditions.
i) Predicted FEV1.0 <= 800mL
ii) PaO2 >= 65 torr(room air) or SaO2 >= 94% (room air)
6)Performance Status(ECOG) is 0 or 1.
7)Hugh-Jones classification is I, II or III.
8)Checked about heart disease.
9)Checked about COPD.
10)Blood examinations fulfill following conditions
i) WBC>=3,000 /mm3
ii) Hb>=8.0 g/dL
iii) Plt>=10x104 /mm3
iv) AST<=100 U/L
v) ALT<=100 U/L
vi) T-bil<=2.0 mg/dL
vii) Cre<=1.5 mg/dL
11) Written informed consent.
Second stage registration
Preoperative criteria
1)Sufficient organ functions.
2)Preoperative body temperature is 38C or less.
Intraoperative criteria
1)The date of surgery (second registration) is within 42 days of the first registration.
2)Non-small cell lung carcinoma is diagnosed. Neither carcinoid nor large-cell neuroendocrine carcinoma.
3)Neither malignant pleural effusion nor pleural dissemination.
4)No inter-lobe PL3.
5)Pleural lavage cytology is not imperative and that result dose not affect the eligibility.
6)Completion of lobectomy and selective lymph node dissection. Metastasis is not diagnosed with frozen examination in the representative lymph nodes, including cN1, which are defined in the protocol.
7)No mediastinoscopy.
8)Latissimus dorsi and serratus anterior muscles are not cut completely.
9)Single lobectomy without angioplasty and bronchoplasty.
Key exclusion criteria
1)Simultaneous or metachronous (within the past 2 years) double lung cancers.
2)Past history of #7 lymph node dissection for contralateral lung cancer resection.
3)Preoperative mediastinoscopy.
4)Interstitial pneumonitis.
5)Active bacterial or fungous infection.
6)Psychiatric disease.
7)Systemic steroids medication.
8)Uncontrollable diabetes mellitus.
9)Uncontrollable hypertension.
10)Past history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
11)The attending doctor does not identify as eligible clinically.
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Miyoshi |
Organization
Okayama University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7265
surgery2@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Soh |
Organization
Okayama University Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7265
Homepage URL
surgery2@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Thoracic Surgery Study Group
Institute
Department
Personal name
Funding Source
Organization
Donation for research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019491
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