UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005908 |
|---|---|
| Receipt number | R000006980 |
| Scientific Title | A phase II study of limited resection for the patient having pulmonary adenocarcinoma with groung glass opacity selected by HR-CT and PET findings |
| Date of disclosure of the study information | 2011/07/03 |
| Last modified on | 2018/01/04 10:21:57 |
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Basic information
Public title
A phase II study of limited resection for the patient having pulmonary adenocarcinoma with groung glass opacity selected by HR-CT and PET findings
Acronym
A phase II study of limited resection for the patient having pulmonary adenocarcinoma with groung glass opacity selected by HR-CT and PET findings
Scientific Title
A phase II study of limited resection for the patient having pulmonary adenocarcinoma with groung glass opacity selected by HR-CT and PET findings
Scientific Title:Acronym
A phase II study of limited resection for the patient having pulmonary adenocarcinoma with groung glass opacity selected by HR-CT and PET findings
Region
| Japan |
Condition
Condition
pulmonary adenocarcinoma with ground glass opacity
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate whether the prognosis of the patient having pulmonary adenocarcinoma with groung glass opacity and low FDG uptake is inferior or not after limited resction
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival rate
Key secondary outcomes
proportion of local recurrence, relapse-free survival, changes of the pulmonary function
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
| Maneuver |
Interventions/Control_1
Limited resection is performed for the patient having pulmonary adenocarcinoma with groung glass opacity, lower FDG uptake than mediastinum, and suspicion of the non-invasive carcinoma by intraoperative pathological examination.
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pulmonary adenocarcinoma
20mm or smaller in HR-CT findings
gropund glass opacity is dominant in HR-CT findings
maximum diameter of the consolidation is shorter than 20% of the maximum diameter of the tumor in HR-CT findings
FDG uptake of the tumor is lower than that of mediastinum
cT1N0M0
possible for lobectomy
written informed consent
non-invasive carcinoma is suspected by intraoperative pathological examination
Key exclusion criteria
multiple cancer within 5 years
preoperative treatment
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyasu Sagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Endoscopy
Zip code
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai 983-8512, Japan
TEL
022-259-1221
sagawam@hosp.tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyasu Sagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Endoscopy
Zip code
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai 983-8512, Japan
TEL
022-259-1221
Homepage URL
sagawam@hosp.tohoku-mpu.ac.jp
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2011 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ejcts/advance-article-abstract/doi/10.1093/ejcts/ezx418/4718127?redirectedF
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ejcts/advance-article-abstract/doi/10.1093/ejcts/ezx418/4718127?redirectedF
Number of participants that the trial has enrolled
Results
From November 2006 to April 2012, 73 patients were collected from 13 institutions. One patient was ineligible and remaining 72 patients were pre-registered. The tumors of 3 and 14 cases were intraoperatively diagnosed as benign lesions and adenocarcinomas with mixed subtype, respectively. Intraoperative cytological/histological examination of surgical margin was not performed in 2 cases, and remaining 53 patients were ultimately eligible for this study.
The mean tumour size was 14.0 mm and the mean GGO ratio was 95.9%. Thirty-nine and 14 patients underwent wedge resection and segmentectomy, respectively. Although all tumors were intraoperatively diagnosed as bronchioloalveolar carcinomas, 6 were ultimately diagnosed as adenocarcinoma with mixed subtype. No completion lobectomy was performed.
As of May 1, 2017, no recurrence of the original lung cancer was observed during 60.0-126.3 months after surgery. Two patients died from other diseases. The 5-year disease-specific and overall survival rates were 100% and 98.1%, respectively. The reduction in the pulmonary function after limited resection was minimal.
With these criteria, limited resection was performed safely without any recurrence, and the postoperative pulmonary function was well-preserved. The outcomes of limited resection for small-sized lung cancer with GGOs that met the criteria of this study were satisfactory.
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
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2011 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006980
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
