OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2030

Conditions
Colorectal CancerMetastatic Cancer
Interventions
OTHER

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.

OTHER

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.

Trial Locations (2)

7100

RECRUITING

Department pf Oncology, Vejle Hospital, Vejle

8200

RECRUITING

Department of Oncology, Aarhus University Hospital, Aarhus N

All Listed Sponsors
collaborator

Vejle Hospital

OTHER

collaborator

Zealand University Hospital

OTHER

lead

Karen-Lise Garm Spindler

OTHER