Prevention of recurrent disease by additional chemotherapy in patients with detectable circulating tumor DNA in the blood after surgery for stage II (lymph nodes unaffected) colon cancer.
- Conditions
- Stage II colon cancer, adjuvant chemotherapy, circulating tumor DNA
- Registration Number
- NL-OMON25151
- Lead Sponsor
- Dutch Colorectal Cancer Group (DCCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1320
Inclusion Criteria
1. Inclusion in PLCRC cohort study, informed consent for repeated blood withdrawals and invitation for future researh
2. Inclusion in observational substudy PLCRC-MEDOCC
Exclusion Criteria
1. Incomplete resection (R1 or R2 resection)
2. Other malignancy in previous 5 years (except for skin cancer other than melanoma and carcinoma in situ)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence Rate (RR) 2 years after surgery
- Secondary Outcome Measures
Name Time Method - 5-year Recurrence Rate<br /><br>- 5 and 7-year overall survival (OS)<br /><br>- quality of life (QoL) <br /><br>- cost-effectiveness analysis