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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005908
Receipt No. 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

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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
Email 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
Email sagawam@hosp.tohoku-mpu.ac.jp

Sponsor
Institute Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006980

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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