UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000039205 |
|---|---|
| Receipt number | R000044197 |
| Scientific Title | Genetic Alterations and clinical record in radically resected colorectal cancer revealed by Liquid biopsy And whole eXome analYsis |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2024/06/03 09:53:59 |
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Basic information
Public title
Genetic Alterations and clinical record in radically resected colorectal cancer revealed by Liquid biopsy And whole eXome analYsis
Acronym
GALAXY trial
Scientific Title
Genetic Alterations and clinical record in radically resected colorectal cancer revealed by Liquid biopsy And whole eXome analYsis
Scientific Title:Acronym
GALAXY trial
Region
| Japan | Asia(except Japan) |
Condition
Condition
Colon and Rectal cancer that can be treated radically
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
A registry pertaining to the relationship between a clinical course and genetic alteration detected from tumor and blood samples will be established through performing the entire exon analysis using tumor samples in patients with colon and rectal cancer planned for radical surgical treatment.
Basic objectives2
Others
Basic objectives -Others
Disease Registry database construction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All: Disease-free Survival
Cohort D: Sensitivity and specificity of ctDNA for the presence of lymph node metastases in additional colorectal resections
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible subjects shall meet all of the following. Patients who have recurrence after the initial registration and are eligible for radical surgical resection again can be re-registered.
(1)Histopathologically diagnosed with adenocarcinoma.
(2)The primary location of the tumor is the colon or rectum.
(3)
CohortA
The clinical stage is equivalent to stage II, III colon cancer (including rectosigmoid) for which R0 resection has been scheduled.
CohortB
The clinical stage is equivalent to stage II, III rectal cancer (excluding rectosigmoid) for which R0 resection has been scheduled. Patients with lateral lymph node metastasis can be included in this cohort.
CohortC
The clinical stage is equivalent to stage IV or relapse (M1) colorectal cancer for which R0 resection has been scheduled.
CohortD
pT1 colorectal cancer after local resection, and additional colorectal resection with lymph node dissection is planned due to non-curative factors.
Non-curative factors are as follows
1.T1b (SM invasiveness >1000 um)
2.Positive vascular invasion
3.Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, mucinous carcinoma
4.Presence of individual cells and small clusters of tumor cells at the invasive front of carcinoma (budding) Grade 2/3
CohortE
The pathological stage is equivalent to stage IIB, IIC, III colorectal cancer for which R0 resection was performed within 48 weeks prior to enrollment. Rectal cancer (excluding rectosigmoid) with lateral lymph node metastasis can be included in this study. And a standard peri-operative (neoadjuvant/adjuvant) chemotherapy according to the country guideline and/or medical practice is scheduled to be performed, is being performed, or has been performed.
(4)The age at the time of acquisition of informed consent is 20 years or older.
(5)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
(6)The subject has given a written informed consent for participation in this study.
Key exclusion criteria
(1) Two or more synchronous colorectal cancer (multiple cancer) *
* In case of patients with stage II, III, IV or recurrent (M1) colorectal cancer according to the 8th edition of the UICC, patients with clinical stage Tis or T1a colorectal cancer judged to be cured by local treatment may be included in this study.
* If patients with pT1 colorectal cancer after local resection (complete en bloc resection with negative margins), have other cancers up to clinical stage T1a that can be judged to be cured by local treatment, registration is possible only if it is confirmed that the cancer was radically resected by local treatment.
(2) Active double cancer.
(3) In case of enrolled in Cohort A or Cohort D, history of surgery, chemotherapy, immunotherapy, or radiotherapy within 6 months before enrollment.
(4) Pregnant or breastfeeding women.
(5) Serious complication.
(6) Positive for HBs antigen or positive for HCV antibody*.
*Patients who are positive for HCV antibody but negative for HCV-RNA is eligible.
(7) HIV antibody positive (a patient may enroll even if HIV antibody has not been tested).
(8) Active novel coronavirus infection (COVID-19) is present*.
* Patients with positive SARS-CoV-2 PCR or suspected COVID-19 based on clinical symptoms; patients with confirmed negative SARS-CoV-2 PCR or other tests and no symptoms of COVID-19 may be include in this study. However, if the physician deem that the patients will affect the evaluation of this study, the patients are ineligible. (COVID-19 testing is not required).
(9) The study doctor deemed that it is ineligible for this study.
Target sample size
6300
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kotani |
Organization
National Cancer Center
Division name
Hospital East, Department of Gastroenterology and GI Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
dkotani@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Mishima |
Organization
National Cancer Center
Division name
Hospital East, Department of Gastroenterology and GI Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
smishima@east.ncc.go.jp
Sponsor or person
Institute
National Research and Development Agency, National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development.
National Research and Development Agency, National Cancer Center.
Alpha-A Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
NCC_IRBoffice@ml.res.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
| 2020 | Year | 01 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A total of 6,300 subjects are planned for enrollment in the following five cohorts.
A. Colon cancer at Stage II/III (at the time of surgery in the UICC 8th edition) (including RS)
B. Rectal cancer at Stage II/III (B1 at surgery, Bs and B2 at diagnosis in the UICC 8th edition)
C. Radically resectable colon and rectal cancer at Stage IV or relapse (M1)
D. pT1 colorectal cancer after local resection (complete en bloc resection with negative margins).
Rationale for the setting of the subject number: In consideration of the limitations of research budgets and the study period, a total of 5,000 subjects were considered able to be accumulated within the study period.
E. The pathological stage is equivalent to stage IIB, IIC, III (at the time of surgery in the UICC 8th edition) colorectal cancer for which R0 resection was performed within 48 weeks prior to enrollment.
Management information
Registered date
| 2020 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044197
