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

Email

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/

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name