Status:
Recruiting
Disease Site:
Colorectal
Phase:
Phase II, Phase III
Official Title:
NRG-GI008: Colon Adjuvant chemotherapy based on evaluation of residual Disease (CIRCULATE-US)
NCT ID:
NCT#05174169
Link to Full Details:
Description:
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.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection.
- Interval between surgery (post-op day &) and study entry must be no more than 60 days
- Must be a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
Exclusion Criteria:
- Colon cancer histology other than adenocarcinoma
- Radiographic evidence of overt metastatic disease
- Prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as tx for colorectal cancer (e.g. primary colon adenocarcinomas for which tx with neoadjuvant chemo and/or radiation is warranted are not permitted)
- Rectal adenocarcinomas synchronous primary rectal and/or colon cancers
- Peripheral neuropathy ≥ grade 2
- Patients whose tumors are MSI-H or dMMR