NRG-GI008: COLON ADJUVANT CHEMOTHERAPY BASED ON EVALUATION OF RESIDUAL DISEASE (CIRCULATE-US)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Colon Cancer
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. (1) Patients must have histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria.
    2. (2) No radiographic evidence of overt metastatic disease within 28 days prior to study entry.
    3. (3) The patient must have had an en bloc complete gross resection of tumor (curative resection).
    (4) The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera assay by Natera. (5) The patient must have an ECOG performance status of 0 or 1. (6) Patients must have histologically/pathologically confirmed Stage II or Stage IIIC colon adenocarcinoma (T4, N2) with R0 resection accordingly to AJCC 8th edition criteria with a positive commercially obtained SIGNATERA(TM) ctDNA positive assay.

You may not be eligible for this study if the following are true:

  • Patients with any of the following conditions are NOT eligible for this study:
    1. (1) Colon cancer histology other than adenocarcinoma.
    2. (2) Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
    3. (3) Tumor-related bowel perforation.
    4. (4) History of bone marrow or solid organ transplantation.



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