UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010934
Receipt number R000012795
Scientific Title A phase II study of surgical treatment for non-small cell lung cancer patients with distant oligometastases
Date of disclosure of the study information 2013/06/12
Last modified on 2022/06/20 08:11:06

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Basic information

Public title

A phase II study of surgical treatment for non-small cell lung cancer patients with distant oligometastases

Acronym

A phase II study of surgical treatment for non-small cell lung cancer patients with distant oligometastases

Scientific Title

A phase II study of surgical treatment for non-small cell lung cancer patients with distant oligometastases

Scientific Title:Acronym

A phase II study of surgical treatment for non-small cell lung cancer patients with distant oligometastases

Region

Japan


Condition

Condition

Non-small cell lung cancer with distant oligometastases

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of surgical treatment for non-small cell lung cancer patients with distant oligometastases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

Relapse free survival, Postoperative PS, Postoperative morbidity


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

Complete resection of primary lung cancer and synchronous or metachronous distant metastasis.

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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Complete resection for primary lung cancer
2)Synchronous or metachronous distant metastasis is located in one organ (3 lesions and less), and R0 resection is possible
3)Performance status 0-1
4)Preoperative evaluation with CT, MRI and PET
5) Neither malignant pleural effusion (pleural dissemination) nor malignant pericardial effusion
6) Sufficient organ functions
7) Written informed consent

Key exclusion criteria

1)Preoperative therapy for primary lung cancer
2)c/pN2
3)Direct extrapulmonary extension
4)With bone metastasis
5)With bilateral adrenal metastases
6)With bilateral renal metastases
7)With active double cancers within 5 years
8)With local recurrence (in a case having metachronous metastasis)
9)Metastasis more than 5 years after operation of primary lung cancer (in a case having metachronous metastasis)
10)Clinically significant complications

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Okada

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Thoracic Surgery

Zip code

9800872

Address

4-1Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-8526

Email

yoshinori.okada.a1@tohoku.ac.jp


Public contact

Name of contact person

1st name Tohru
Middle name
Last name Hasumi

Organization

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

Division name

Central study center

Zip code

9800872

Address

4-1Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-8526

Homepage URL


Email

hasumi.toru.fd@mail.hosp.go.jp


Sponsor or person

Institute

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

Institute

Department

Personal name



Funding Source

Organization

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japanese Northern East Area Thoracic Surgery Study Group (JNETS)

Address

2-11-12Miyagino,Miyagino-ku, Sendai

Tel

022-717-8526

Email

jnets@grp.tohoku.ac.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

2013 Year 06 Month 12 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

55

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

2003 Year 03 Month 31 Day

Date of IRB

2003 Year 04 Month 21 Day

Anticipated trial start date

2003 Year 12 Month 12 Day

Last follow-up date

2022 Year 04 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 12 Day

Last modified on

2022 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name