UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047858
Receipt number R000054565
Scientific Title Outcome of pulmonary metastasectomy of colorectal cancer followed by adjuvant chemotherapy according to the prognostic index: A subset analysis of prospective multicenter study
Date of disclosure of the study information 2022/05/25
Last modified on 2024/02/13 14:54:29

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Basic information

Public title

Outcome of pulmonary metastasectomy of colorectal cancer followed by adjuvant chemotherapy according to the prognostic index: A subset analysis of prospective multicenter study

Acronym

WJOG5810GSS

Scientific Title

Outcome of pulmonary metastasectomy of colorectal cancer followed by adjuvant chemotherapy according to the prognostic index: A subset analysis of prospective multicenter study

Scientific Title:Acronym

WJOG5810GSS

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of the previously proposed prognostic index for metastasectomy for pulmonary metastasis of colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

Usefulness

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of the ability and reproducibility of risk classification by the prognostic index.

Key secondary outcomes

None


Base

Study type

Others,meta-analysis etc


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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Potentially curative R0 resection was performed for patients with lung metastases from colorectal cancer.
2)Initial lung metastasectomy.
3) Pathological findings should be as follows
i)Histologically proven adenocarcinoma
ii)Less than 4 metastases.
iii)No pulmonary, hilar and mediastinal lymph node metastases.
4) Within 70 days after lung metastasectomy
5) No prior chemotherapy for advanced or metastatic disease.
i)Adjuvant chemotherapy with only FU is allowed.
More than 180 days after the last chemotherapy .
6) No recurrence on chest and abdominal CT or MRI within 4 weeks before enrollment.
7) ECOG performance status 0-1
8)Vital organ functions (listed below) are preserved within 1 week prior to entry.
9) Written informed consent

Key exclusion criteria

1)Adjuvant FU was terminated because of ADR.
2)Multiple cancer patient (within 5 years)
3)Transfusion or blood product or growth factor such as G-CSF less than 14 days prior to entry
4)Have following severe complications.
5)Systemic and continuous steroids medication.
6)Severe peripheral neuropathy.
7)History of the serious hypersensitivity for drugs.
8)Hepatitis B virus infection
9)Clinically significant mental or psychological disease.
10)Not pregnant
11)Patient who is taking flucytosine, phenytoin or warfarin potassium continuously.
12)Other conditions not suitable for this study.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Takehiro
Middle name
Last name Okumura

Organization

Japan Community Health Care Organization Saitama Medical Center

Division name

Thoracic Surgery

Zip code

330-0074

Address

4-9-3 Kitaurawa, Urawa-ku, Saitama,JAPAN

TEL

048-832-4951

Email

taokumura@gmail.com


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

556-0016

Address

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

West Japan Oncology Group

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

Shizuoka Cancer Center

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 JAPAN

Tel

055-989-5222

Email

rinsho_office@scchr.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 05 Month 25 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


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

Completed

Date of protocol fixation

2022 Year 04 Month 30 Day

Date of IRB

2022 Year 07 Month 05 Day

Anticipated trial start date

2022 Year 07 Month 05 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The backgrounds of patients with pulmonary metastases of colorectal cancer vary widely. Therefore, a risk classification that predicts prognosis of these patients may be useful to investigate treatment strategies. The previous multicenter retrospective study (Ann Thorac Surg 104: 979-987, 2017) identified a prognostic index based on prognostic factors obtained before metastasectomy and proposed a risk classification to predict prognosis after metastasectomy. However, the clinical significance of this risk classification has not been investigated.


Management information

Registered date

2022 Year 05 Month 25 Day

Last modified on

2024 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name