UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048902 |
|---|---|
| Receipt number | R000055721 |
| Scientific Title | Evaluation of long-term prognosis after resection for early-stage non-small cell lung cancer (JCOG0707A1) |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2023/03/13 15:52:16 |
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Basic information
Public title
Ancillary study for the "phase III Study of adjuvant chemotherapy for the patients resected pathological stage I (T1>2cm) non-small cell lung cancer": Evaluation of long-term prognosis after resection for early-stage non-small cell lung cancer (JCOG0707A1)
Acronym
Ancillary study for the "phase III Study of adjuvant chemotherapy for the patients resected pathological stage I (T1>2cm) non-small cell lung cancer": Evaluation of long-term prognosis after resection for early-stage non-small cell lung cancer (JCOG0707A1)
Scientific Title
Evaluation of long-term prognosis after resection for early-stage non-small cell lung cancer (JCOG0707A1)
Scientific Title:Acronym
Evaluation of long-term prognosis after resection for early-stage non-small cell lung cancer (JCOG0707A1)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An ancillary study will be conducted on patients enrolled in the JCOG0707, "phase III Study of adjuvant chemotherapy for the patients resected pathological stage I (T1>2cm) non-small cell lung cancer", to elucidate the frequency of the late recurrence of lung cancer and the sites most likely to recur, based on the long-term follow-up data. In addition, the relationship between the death from primary lung cancer and the death from other disease will be assessed by examining the frequency of secondary cancers and the causes of deaths from other diseases. Furthermore, the relationship between deaths from secondary cancers and deaths from non-cancer causes among other disease deaths will be ascertained.
Basic objectives2
Others
Basic objectives -Others
To elucidate the long-term prognosis after surgery for early-stage lung cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence-free survival, site of recurrence, cumulative incidence of secondary cancer, cumulative incidence of death from primary lung cancer, cumulative incidence of all causes of deaths (deaths from cancers and deaths from non-cancer causes)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Total 963 patients registered for the JCOG0707: "phase III Study of adjuvant chemotherapy for the patients resected pathological stage I (T1>2cm) non- small cell lung cancer"
Key exclusion criteria
Not applicable
Target sample size
963
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kunitoh |
Organization
Japanese Red Cross Medical Center
Division name
Medical Oncology
Zip code
150-8935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
kunito_hideo@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Yotsukura |
Organization
JCOG0707A1 Coordinating Office
Division name
National Cancer Center Hospital, Department of Thoracic Surgery
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
http://www.jcog.jp/
mayotsuk@ncc.go.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel
03-3542-2511
irst@ncc.go.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
| 2022 | Year | 09 | 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
963
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, all patients enrolled in the JCOG0707 will be subjected to a prognostic survey; the analysis will be based on the existing data of the JCOG0707 stored at the JCOG Data Center and the data obtained from the prognostic survey in this study.
Management information
Registered date
| 2022 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055721
