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NRG-GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Overall Recruitment Status: Active, currently enrolling

Official Title

NRG-GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Region

Sponsors

Mid-Atlantic

National Cancer Institute (NCI)

NRG Oncology

Acronym

KP IRB No.

1949437

Study Type

Phase

Clinical Trial

Phase II

Study Population Description

Adults 18+ with Stage III colon cancer

Purpose

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Detailed Description

Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.

Gender

Age Limit

Male & Female

Inclusion Criteria

ECOG performance status of 0 or 1

Histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria.

Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.

Treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).

Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.

Exclusion Criteria

Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).

Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.

Tumor-related bowel perforation.

History of prior invasive colon malignancy, regardless of disease-free interval.

History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.

Keywords and/or Specific Medical Conditions