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. 2021 Jun 7;112(7):2915–2920. doi: 10.1111/cas.14926

TABLE 1.

Eligibility criteria of the GALAXY trial

Inclusion criteria
  • 1.

    Histopathologically diagnosed with adenocarcinoma

  • 2.

    The primary location of the tumor is the colon (cecum, colon, and rectosigmoid) or rectum (excluding appendix and anal canal cancer)

  • 3.

    The clinical stage is stage II, III, IV or relapse (M1) for which R0 resection has been scheduled (UICC TNM Classification, 8th Edition)

  • 4.

    The age at the time of acquisition of informed consent is 20 y or older

  • 5.

    Eastern Cooperative Oncology Group Performance Status is 0 or 1

  • 6.

    The subject has given a written informed consent for participation in this study

Exclusion criteria
  • 1.

    Two or more synchronous colorectal cancer (multiple cancer)*

*Patients with clinical stage Tis or T1a colorectal cancer judged to be cured by local treatment may be included in this study
  • 2.
    Active double cancer*
*However, patients with a relapse‐free survival period of 5 y or longer or patients with skin basal cell or spinocellular cell carcinoma which has been considered cured by local treatment, superficial bladder cancer, cervical cancer, carcinoma in situ (intraepithelial cancer) that can be treated endoscopically, lesions equivalent to intramucosal cancer, or nonmetastatic prostate cancer that does not require systemic treatment may be enrolled
  • 3.
    History of surgery, chemotherapy, immunotherapy, or radiotherapy within 6 mo before enrollment with clinical stage II or III colon cancer (cecum, colon, rectum sigmoid)
  • 4.
    Pregnant or breastfeeding women
  • 5.
    Serious complication
  • 6.
    Positive for hepatitis B surface (HBs) antigen or positive for hepatitis C virus (HCV) antibody
  • 7.
    Human immunodeficiency virus (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 included in this study. However, if the physician deems 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