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RECRUITING
NCT04680260
PHASE2

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

Sponsor: Karen-Lise Garm Spindler

View on ClinicalTrials.gov

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

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.

Locations (2)

Department of Oncology, Aarhus University Hospital

Aarhus N, Denmark

Department pf Oncology, Vejle Hospital

Vejle, Denmark