OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Metastatic Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: An open label 1:1 randomized phase II exploratory studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ther...
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.
Tracking Information
- NCT #
- NCT04680260
- Collaborators
- Vejle Hospital
- Zealand University Hospital
- Investigators
- Principal Investigator: Karen-Lise G Spindler, Professor Department of Oncology, Aarhus University Hospital
Get Well Soon