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
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
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
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
