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OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
Sponsor: Karen-Lise Garm Spindler
Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
Official title: OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2021-10-25
Completion Date
2030-03-01
Last Updated
2024-08-14
Healthy Volunteers
No
Conditions
Interventions
Standard of care
Patients will be offered adjuvant chemotherapy according to standard of care. Follow up will be performed with imaging according to standard guidelines, equal to the experimental arm. Blood samples will be analyzed retrospectively to evaluate the ctDNA status.
Circulating tumor DNA guided treatment approach
Circulating tumor-marker positivity will lead to escalation with 6 months of intensified chemotherapy consisting of 4 months of FOLFOXIRI followed by 2 months of 5FU monotherapy. Circulating tumor-marker negativity will based on shared decision-making lead to de-escalation i.e. possibilities for observation in patients otherwise eligible for monotherapy or observation/monotherapy in patients, otherwise eligible for combination chemotherapy according to standard of care.
Locations (2)
Department of Oncology, Aarhus University Hospital
Aarhus N, Denmark
Department pf Oncology, Vejle Hospital
Vejle, Denmark