UMIN-CTR Clinical Trial

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

Colon and Rectal cancer that can be treated radically

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

dkotani@east.ncc.go.jp

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

Email

smishima@east.ncc.go.jp

Institute

National Research and Development Agency, National Cancer Center

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public 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 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.

Registered date

2020

Year

01

Month

20

Day

Last modified on

2022

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044197