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1 Study Matches

Site for (22-070) Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US) (NRG-GI008)

To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.

We are asking you to take part in this research study because you have colon cancer that has been treated with surgery but has spread to some of your lymph nodes and is known as stage III colon cancer. Or, you have stage II or stage III colon cancer with a higher risk of cancer returning, your colon cancer has been treated with surgery, and you had ctDNA testing done and are ctDNA positive. Stage II colon cancer is an early stage colon cancer that has been treated with surgery but has not spread to your lymph nodes. ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

Nelson Yee 717-531-5471

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
patient must be ≥ 18 years old.
Hemoglobin must be ≥ 9 g/dL
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
The patient must have an ECOG performance status of 0 or 1

Exclusion Criteria:
Colon cancer histology other than adenocarcinoma
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
Not applicable
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Location Contacts
Hershey, PA ,