Circulating tumor DNA based adjuvant chemotherapy in stage II colon cancer patients: the MEDOCC-CrEATE trial
Recruiting
- Conditions
- large bowel cancer10017991Colon carcinoma10017990
- Registration Number
- NL-OMON54658
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1320
Inclusion Criteria
- Age >= 18 years
- Informed consent for PLCRC with specific consent for additional blood
withdrawals, collection of tissue and being informed about future experimental
research
- Histological confirmed stage II colon cancer
- Fit for combination chemotherapy (fluoropyrimidin and oxaliplatin) according
to the treating physician
Exclusion Criteria
- Indication for adjuvant chemotherapy according to treating physician
- Another malignancy in previous 5 years, except carcinoma in situ or skin
cancer other than melanoma
- Incomplete tumor resection (R1 or R2 resection)
- Contra-indications for fluoropyrimidines or oxaliplatin
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients with detectable ctDNA in their blood starting with<br /><br>chemotherapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Recurrence Rate 2 years after surgery (intention-to-treat analysis)<br /><br>- 2-year RR in a per-protocol analysis<br /><br>- 5-year RR (intention-to-treat and per-protocol)<br /><br>- 2- and 5-year disease free survival (DFS) rate<br /><br>- disease-related 5- and 7-year overall survival (OS) rate<br /><br>- quality of life (QoL), RR in patients without detectable ctDNA after surgery<br /><br>- time-to-recurrence (TTR)<br /><br>-cost-effectiveness of the ctDNA-based treatment. </p><br>