Spots Global Cancer Trial Database for OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
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Trial Identification
Brief Title: OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
Official Title: OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
Study ID: NCT04680260
Study Description
Brief Summary: A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
Detailed Description: An open label 1:1 randomized phase II exploratory study investigating use of ctDNA-guided adjuvant chemotherapy compared to standard of care (SOC) after local treatment for metastatic colorectal cancer. Patients are randomized 1:1 between SOC and ctDNA guided treatment and follow-up. Escalation therapy comprises standard regimen of Fluorouracil (5-FU), Irinotecan and oxaliplatin (FOLFOXIRI), de-escalation therapy of monotherapy capecitabine or observation only. SOC is per institutional practice, based on national guidelines.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Oncology, Aarhus University Hospital, Aarhus N, , Denmark
Department pf Oncology, Vejle Hospital, Vejle, , Denmark
Contact Details
Name: Karen-Lise G Spindler, Professor
Affiliation: Department of Oncology, Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
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